The Pharma Legal Handbook: South Africa
The Pharma Legal Handbook: South Africa answers essential questions about the legal and regulatory environment for pharmaceuticals in South Africa. It is a must-have for any company operating in the country or looking to enter the market.
Prepared in association with Fasken, a leading international law firm, it should answer any questions linked to regulation, pricing, clinical and preclinical trials, marketing, manufacturing, trademarks and patents.
If legal handbook content is updated, you will receive a free updated PDF for up to one year after purchase.
Last Update October 2018
1. Cannabinoid Drugs and Medicinal Cannabis: South Africa
1. Are Cannabinoid Drugs authorized in your country?Cannabis use is illegal in most countries and until recently this included South Africa. In terms of the Drugs and Drug Trafficking Act (“the Drugs Act”) it is illegal to deal in, possess or sell Cannabinoid drugs in South Africa. This stance has however been changed recently by the Constitutional Court of South Africa’s Judgement that now make it legal to make use of or possess Cannabis in private by an adult person for his or her own consumption in private. Furthermore, certain regulations which specifically govern medicines containing cannabis, cannabis extracts, and cannabis-derived substances such as cannabinoids, which must registered with SAHPRA, has been found to be inconsistent with the right to privacy entrenched in Section 14 of the Constitution. These substances were rescheduled and listed in Schedule 6 to bring them in line with the scheduling status of other restricted medicines, thus allowing patients to access medicinal cannabis products by prescription at a pharmacy. Any cannabis products not registered by SAHPRA remain in Schedule 7 and were technically still illegal. However, in August 2017 and prior to the Constitutional Court Judgement of 18 September 2018, SAHPRA released a Communication to Industry document in which they indicated that Cannabidiol specifically was down-scheduled from Schedule 6 to Schedule 4. The above will however be affected by the Constitutional Court Judgement handed down on 18 September 2018.
2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?The South African Health Products Regulatory Authority (SAHPRA) is responsible for regulating all medicines and medical devices in South Africa by ensuring that they meet standards of efficacy, safety and quality. SAHPRA operates in terms of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) (“the Medicines Act”), the Regulations issued in terms of that Act, and associated Guidelines. The Department of Health is the Government structure responsible for the implementation and management of the Medicines Act. The Drug Trafficking Act also applies in addition to, and not in substitution for, the provision of the Medicines Act or any regulation made thereunder (Section 2) and is administered by the Department of Justice and Constitutional Development. The Judgement in the Prince matter has created somewhat of a disruption to the longstanding viewpoint on the matter from a legal and regulatory perspective. The Judgement state that the South African Parliament have the onus to ensure the correction and update of the Constitutional defects in the statutory provisions which it identified. Parliament has 24 months from the date of Judgement handed down, to cure the constitutional defects, failing which, the reading-in as done in the Judgement, will become final.
3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?Until the Prince matter had been adjudicated, Cannabinoid Drugs remained illegal in South Africa unless obtained through legal prescription of an authorised medical practitioner. At this time however, there are specific sections in the different Acts and regulations, which will be changed to become operational in line with the Judgement made in this regard. The regulatory framework should potentially stay with the South African Health Products Regulatory Authority where it concerns Medicinal Cannabis and dealing in Cannabis for non-medicinal purposes, remains regulated under the auspices of the Drugs Act.
4. Which are the cannabinoid drugs that have received market approval to date?To date, SAHPRA has registered one medicine containing cannabinoids appearing in the plant and has listed the medicine as a schedule 6 product making it illegal to possess the medicine provided that it has been obtained with a prescription from a medical practitioner. In addition, SAHPRA has also issued authorizations for the use of an unregistered medicine containing cannabinoids. At the time of the Judgement SAHPRA was continuing to work towards implementing a detailed regulatory framework to enable applications for licences and permits for the cultivation, production and manufacture of medical cannabis products. The Prince-judgement however places doubt on the process in its entirety since an adult person is now allowed to cultivate, possess and use Cannabis in private for his or her personal consumption in private or in any other case.
5. Who can prescribe Cannabinoid Drugs?In terms of Sections 21 and 22A (9) (a) (i) of the medicines Act, authorised practitioners can apply to the SAHPRA for permission to access and prescribe unregistered medicines when intended to treat individual patients7. Section 22A(9)(a)(i) read together with Part III of Schedule 2 of the Drugs Act have been found unconstitutional and as such, will in future not apply to the prescription of Cannabinoid drugs. The changes to the relevant legislation must be implemented by the South African Parliament within 24 months of the date of the Judgement, failing which, the parts read-in with regards to the specific Sections, Schedules and Parts of the Medicines and Drugs Act respectively by the Judges of the Constitutional Court, will become final and automatically part of the legislation. It is uncertain however, how the latest Judgement regarding Cannabis cultivation, possession and use will affect the regulation of Cannabis for medicinal use.
6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?Currently the list of medical practitioners who are authorized to prescribe Cannabinoid Drugs is not available to the public.
7. What approvals or notifications are required to prescribe Cannabinoid Drugs?Prior to the Judgement, approval from SAHPRA in terms of Sections 21 and 22A (9) (a) (i) of the medicines Act were required for permission to access and prescribe the cannabinoid drugs without it being registered. There may be significant changes to how this process is managed in light of the changes which must be made in line with the Constitutional Court Judgement.
8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?The cultivation, possession and use of Cannabinoid drugs were illegal in South Africa prior to the Constitutional Court Judgement in the Prince-matter. With this judgement, a person who cultivates, possesses or use Cannabis will not be committing a crime if it is done in private for personal consumption. The cultivation, possession and use of Cannabis have been decriminalised for this pupose.
9. Is there a list of retailers/ distributors authorized to sell Cannabinoid Drugs?No.
10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?Yes, there have been proposals to the SAHPRA, Minister of Health, Department of Health and Parliament – Regulations under the Medicines Act were published on 28 July 2017 in which Cannabidiol is listed as a Schedule 6 medication – this enables a person specifically authorised in terms of Section 22A(5)(f) of the Medicines Act to prescribe or supply, within their scope of practice and subject to indication for use of the substance and in conditions specified by the SAHPRA, Cannabidiol to patients under their care. SAHPRA published a Guideline on the Cultivation of Cannabis and Manufacture of Cannabis-Related Pharmaceutical Products for Medicinal and Research Purposes. This Guideline indicate that to date, patient access to unregistered Cannabis or cannabinoid-containing medicines has been enabled by SAHPRA through importation of these products under strict control and regulation measures. A framework was developed in consultation with the Department of Agriculture, Forestry and Fisheries (DAFF), the Department of Health and SAHPRA. This framework has the goal to ensure the availability of standardised quality-assured locally grown Cannabis for the manufacture of suitable pharmaceutical products. The intention is to control the cultivation, production and manufacturing of Cannabis-containing products intended for medicinal use in South Africa. Last mentioned however, will probably be reviewed and updated in light of the Constitutional Court Judgement and the legislative changes that will be following within the next 24 months.
11. When are they likely to come into force?The above mentioned Regulation came into force on the date of publication in the Government Gazette which is 28 July 2017. They are however subject to change in light of the Constitutional Court Judgement.
1. Is Medicinal Cannabis authorized in the country?The Medicines Act, through the provisions of Section 22A (9) (a) (i), allows for the acquisition, use, possession, manufacture or supply of Cannabis for medicinal use by a medical practitioner, analyst, researcher or veterinarian for the treatment or prevention of a medical condition in a particular patient, or for the purposes of education, analysis or research, provided that a permit is obtained from the Director-General of Health. Section 22A(9)(i) has however been found to be unconstitutional and as such, will be changed to include wording that indicate in the case of cannabis, should the person be an adult male or female and the Cannabis is used or in their possession in private for personal consumption in private or in any other case. It would not be deemed a criminal act and will carry no punishment. This is in stark contrast to how Cannabis cultivation, possession and use were regulated prior to the Prince-matter. SAHPRA would need to make changes to the guidelines in this regard once changes to this Section in the Medicines Act have been changed in accordance with the requirements and findings as set out in the Constitutional Court Judgement.
2. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?The South African Health Products Regulatory Authority (SAHPRA) in conjunction with the Department of Health.
3. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?The current legislative framework to allow for domestic cultivation of medicinal cannabis is currently under development (and has been since 2016) by the Department of Health in consultation with the South African Health Products Regulatory Authority. It will undergo further changes to include the requirements as set out in the recent Constitutional Court Judgement which found that Cannabis cultivation, possession and use in private for personal consumption in private, is not illegal. In terms of Sections 21 and 22A (9) (a) (i) of the medicines Act, authorised practitioners can apply to the SAHPRA for permission to access and prescribe unregistered medicines when intended to treat individual patients. Section 22A(9)(i) have been found unconstitutional and changes made to how it reads in order to exclude Cannabis cultivation, possession and use from being a criminal activity. How SAHPRA regulates Medicinal Cannabis will depend on the changes to be made to the Medicines Act in this regard. Cannabis-containing products intended for medicinal purposes may thus be made available, in exceptional circumstances, to specific patients under medical supervision. In addition, the Medicines Act allows SAHPRA to issue a licence to manufacture either a medicine or a Scheduled substance (Active Pharmaceutical Ingredient/API). Section 22(C) (1) (b) of the Medicines Act enables the cultivation and manufacture of the Scheduled substances and ensures the required oversight of SAHPRA in regulating these activities. This provision allows SAHPRA to license cultivators of Cannabis for medicinal use and enables regulatory oversight in a way that is compliant with South Africa’s international obligations. The legislative framework addresses three regulatory aspects:
- Authorisation of Cannabis cultivation and production domestically, for medicinal and research purposes.
- Satisfying the requirements of South Africa’s international obligations, under the Single Convention.
- Aligning the access of Cannabis-containing products for medicinal purposes with that of other controlled medicines.
4. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?Until now, patient access to unregistered Cannabis or cannabinoid-containing medicines has been enabled by SAHPRA through importation of these products. In order to ensure the availability of standardised quality-assured locally grown Cannabis for the manufacture of suitable pharmaceutical products, the Department of Health and SAHPRA may permit the cultivation of Cannabis solely for medicinal and research purposes. This process may however undergo changes due to the inevitable changes which will be made to the relevant legislation in this regard. Access to medicines and Scheduled substances in South Africa are controlled through Scheduling of the substance. Cannabis is a prohibited narcotic substance listed under Schedule 7 of the Schedules to the Medicines Act and cultivation for any purpose other than that explicitly allowed for through the licence and permit system under the medicines Act, is a criminal offence. Likewise cultivation by non-licensees remains a criminal offense under this and other legislation. SAHPRA currently hasn’t provided any indication as to how they plan to address the required changes proposed in the Constitutional Court Judgement or what timelines would be involved in the process of implementing the new legal requirements into their current Guidelines and Rules. With the required changes needing to be updated and corrected in National Legislation, this process may take some time before SAHPRA would even be in a position to address the matter from their side and update their documentation accordingly.
5. What approval or notifications are necessary to produce or import Medicinal Cannabis?In terms of Section 22C (1) (b) of the Medicines Act an applicant may apply to SAHPRA for a licence for any or all of the following activities:
- Cultivate/grow and produce Cannabis and Cannabis resin;
- Extract and test Cannabis, Cannabis resin and/or cannabinoids;
- Manufacture a cannabis-containing or cannabinoid-containing medicine;
- Import a Cannabis-containing medicine;
- Export a Cannabis-containing medicines;
- Distribute a Cannabis-containing medicine.
6. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?Access to medicines and Scheduled substances in South Africa is controlled through scheduling of the substance. Cannabis used to be a prohibited narcotic substance listed under Schedule 7 of the Schedules to the Medicines Act and cultivation for any purpose other than that explicitly allowed for through the licence and permit system under the Medicines Act, was a criminal offence. In the recent Constitutional Court Judgement, the Court found that the scheduling of Cannabis is inconsistent with the fundamental rights afforded every citizen in so far it relates to Privacy and this part of the legislation will be changed accordingly. Even though Cannabis is a Schedule 7 drug, the manner in which it’s cultivation, possession and use is regulated in Section 22A(9)(a)(i) and the Government Gazette no R509 of 2003 published in terms of this Section, was found to be inconsistent with the constitutional right to privacy.
7. How can patients obtain Medicinal Cannabis?The only means by which a patient will be able to obtain Medicinal Cannabis in South Africa is through a medical practitioner who holds the relevant licence to prescribe it, which licence is obtained from SAHPRA. A Pharmacist registered accordingly with the relevant Pharmacy Council will be able to provide medicinal cannabis when provided with a legitimate prescription from a medical practitioner as discussed previously. Medicinal Cannabis products may thus be made available to specific patients under medical supervision and through legal channels as confirmed by SAHPRA in the guideline document in this regard. According to the Constitutional Court Judgement the dealing in cannabis remain illegal and as such, it must be acquired through legal means if not cultivated by the person using it in private for their personal consumption.
8. Who can prescribe Medicinal Cannabis?Under the Medicines Act, medical practitioners can apply to SAHPRA for permission to access and prescribe unregistered medicines – including cannabis – for their patients in certain exceptional circumstances. Only registered medical practitioners may apply for authorisation to prescribe a controlled medicine for a specific patient. Authorisation from SAHPRA is dependent on the submission of an appropriate dosage regimen and acceptable justification for the proposed and intended use.
9. Is there a list of doctors authorized to prescribe Medicinal Cannabis?No list of medical practitioners with authorisation to prescribe Medicinal Cannabis was available at the time of this document being drafted.
10. What approvals or notifications are required to prescribe Medicinal Cannabis?Approval from SAHPRA after application to become an authorised prescriber of Medicinal Cannabis – this can only be obtained by a medical practitioner registered with the Health Professions Council of South Africa.
11. Where is Medicinal Cannabis available?At this stage Medicinal Cannabis is only available once prescribed by an authorised medical practitioner with the relevant authority from SAHPRA(through a Section 21 Application which SAHPRA must approve). The dispending is only allowed to be done by an authorised pharmacist in terms of the Medicines Act.
12. Is there a list of retailers authorized to sell Medicinal Cannabis?This information is not available at this time.
13. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?Yes, there have been proposals to SAHPRA, the Minister of Health, Department of Health and Parliament – Regulations under the Medicines Act were published on 28 July 2017 in which Cannabidiol is listed as a Schedule 6 medication – this enables a person specifically authorised in terms of Section 22A(5) (f) of the Medicines Act to prescribe or supply, within their scope of practice and subject to indication for use of the substance and in conditions specified by the SAHPRA, Cannabidiol to patients under their care. Related to the above, is the Constitutional challenge which was brought regarding the recreational use of cannabis. The Judgement has been discussed at length in this document and it is uncertain at this stage how the legislation changes will impact the regulation of medicinal cannabis if recreational cultivation, possession and use by adult males and females in private for their personal consumption is no longer considered a crime.
14. When are they likely to come into force?The Regulations which were proposed to SAHPRA and the Minister of Health and Parliament relating to medicinal cannabis came into force on the date of publication in the Government Gazette which is 28 July 2017. Dealing in cannabis remains illegal, but the personal cultivation, possession and use of cannabis for personal consumption in private, has been legalised.
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2. Regulatory Reforms: South Africa
1. Are there proposals for reform or significant change to the healthcare system?NATIONAL HEALTH INSURANCE BILL AND MEDICAL SCHEMES AMENDMENT BILL On 21 June 2018 the Minister of Health Published the Medical Schemes Amendment Bill and the National Health Insurance (NHI) Bill for comment by the public and interested parties within the respective Industries. In terms of the current environment in South Africa and the Minister of Health (and the Government) aim to achieve adherence to Section 27(2) of the South African Constitution which require for the State to “take reasonable legislative and other measures, within its available resources to achieve the progressive realisation of the right”. The right referred to is the Right to access to health care in terms of Section 27(1) (a) which states “Everyone has the right to have access to health care services, including reproductive health care;” In this regard the National Health Insurance Bill aims to provide mandatory prepayment health care services in the Republic in pursuance of section 27 of the Constitution; to establish a National Health Insurance Fund and to set out its powers, functions and governance structures; to provide a framework for the active purchasing of health care services by the Fund on behalf of users; to create mechanisms for the equitable, effective and efficient utilisation of the resources of the Fund to meet the health needs of users; to preclude or limit undesirable, unethical and unlawful practices in relation to the Fund and its users; and to provide for matters connected herewith. There is a definite link created between these two Bills, where the Medical Schemes Amendment Bill in Section 17 state that the Registrar of Medical Schemes may, after consultation with the Minister, restrict the benefits offered by medical schemes having regard to the benefit and service coverage under the National Health Insurance Fund – the aim apparently being to eliminate duplicative costs for the same benefit. Medical Schemes are not abolished by the NHI Bill and in its current draft there is provision for regulation of the relationship between the NHI Fund and medical and/or other private health insurance schemes. However, the crux of the matter is that the NHI Bill clearly state that where any conflicts between these two Bills are present, the NHI Bill and the Constitution shall prevail. The deadlines on providing comments on these two Bills are three months from the date of publication. Until such time, the current legislative framework in so far it relates to public health care services and medical schemes and its functioning within the private health care sector, remains unchanged.
2. When are they likely to come into force?These two Bills have only been published on 21 June 2018 and will go back to Parliament for consideration after the three-month period for comments have come to an end. The publication of the NHI Bill and Medical Schemes Amendment Bill in the Government Gazette for public comment is followed by referral to the relevant committee within Parliament. It is debated in the relevant committees of Parliament and amended if necessary. If the Bill passes through both the National Assembly and the National Council of Provinces, it goes to the President for assent (where he signs it into law). Once it is signed by the President the Bill becomes an Act of Parliament and a law of South Africa. In so far this process relates to the two proposed Bills, there is still quite some time which will pass in allowing the full and correct procedure to take its course. Therefore, a specific date or timeframe within which these two Bills might come into force is undeterminable at this time.
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3. Patents & Trademarks: South Africa
1. What are the basic requirements to obtain patent and trademark protection?Patents and Trademarks form part of Intellectual property in terms of South African law, where Intellectual Property is defined as: “a generic term used to refer collectively to a variety of diverse intangible products such as inventions and patents, trademarks and brand names, industrial designs, copyright, plant breeders’ rights, performances, trade secrets and know-how etc.” The Patents Act 57 of 1978 and Patent Regulations provide the legal framework within which patent protection can be obtained. Protection of TrademarkTrademarks are provided under the Trademarks Act No 104 of 1993. PATENT PROTECTION A South African Patent Application is not subjected to substantive examination; the Registrar merely examines the application for compliance with the formal requirements of the Act and if he is satisfied, the application will proceed to acceptance and grant. For an application for a patent to be granted certain requirements must be met in terms of the Patents Act. One being that an application for a patent in respect of an invention may be made by the inventor or by any other person acquiring from him the right to apply or by both such inventor and such other person. There are some difficulties in obtaining protection for industrial property rights in any number of countries in the world as a result of the diversity in national laws, and the increasing need to file patent applications in every country in which protection is desired almost simultaneously to avoid a novelty destroying event, created an urgent need for the harmonisation of industrial property laws. The Paris Convention and the Patent Cooperation Treaty (PCT) also apply and both have been accepted by South Africa and entered into force. The PCT is complementary to the Paris Convention. Benefits of the PCT include the effective harmonisation of the filing, searching and examination of patent applications. It is possible to seek patent protection simultaneously in a number of countries by filing a single international application. It is also possible, in addition to last mentioned, for the international application to be subjected to international search and examination, providing the opportunity for critical evaluation and assessment of the application. Since South Africa has acceded to the PCT, it is possible for South African Nationals to proceed by way of PCT international and PCT national phase applications. The Patents Act regulates applications filed under PCT in Chapter VA. It is possible for an international application to be designated to South Africa, subject to provisions of Chapter VA, the application shall be deemed to be an application for a patent lodged at the South African patent office to act as receiving, designated and elected office as set out in Section 43C of the Act. The National phase entry deadline in South Africa is 31 months from the earliest filing date, with allowance for the deadline to be extended for a further three months. This can only be done through a request to the Registrar. Should the applicant fail to enter the national phase within the prescribed deadline, it will result in the application being deemed abandoned for the purposes of the Act. Regulation 22 of the Patent Act provides the information regarding the prescribed manner in which a provisional patent application must be made. Payment of the prescribed fee and provisional specification (as set out in Section 30(1)) of the Act, must accompany this application. Form P1 is the application form which must be used when the applications are made and must be accompanied by the following documents:
- Form P1, in duplicate, one copy of which shall be returned to the applicant as proof of lodging;
- Form P2 in duplicate;
- A declaration and power of attorney on Form P3;
- Where the applicant has acquired a right to apply from the inventor, an assignment or other proof, to the satisfaction of the registrar, of the right of the applicant to apply;
- A single copy of a provisional specification on Form P6 or two copies of a complete specification on Form P7;
- Drawings, in the prescribed manner, if drawings are necessary to exemplify the invention; and
- An abstract on Form P8, in duplicate, if the application is accompanied by a complete specification.
- not be on the excluded list of marks as per Section 10 of the Trademarks Act;
- adhere to the requirements for
- An application for a trademark registration shall be made on Form TM1;
- The application shall be dated and signed by the applicant(s) or his/their duly authorised agent;
- The application shall be in triplicate and a separate and distinct applica tion is required for each class of goods or services and for each separate mark;
- If the application is made by a firm or partnership it may be signed in the name of or for and on behalf of the firm or partnership by any one or more members or partners thereof;
2. What agencies or bodies regulate patents and trademarks?Patents and Trademarks in South Africa are regulated by the Companies and Intellectual Property Commission.
3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?PATENTS WHICH CAN BE PROTECTED In terms of the Patents Act, Section 1 an “invention” is defined as one for which a patent may be granted under Section 25”. In a very general manner certain positive requirements for patentability is set out such as:
- Any new invention which involves an inventive step and which is capable of being used or applied in trade or industry or
- A discovery;
- A scientific theory;
- A mathematical method;
- A literary, dramatic, musical or artistic work or any other aesthetic creation;
- A scheme, rule or method for performing a mental act, playing a game or doing business;
- A program for a computer;
- The presentation of
4. How can patents and trademarks be revoked?A Trademark can be expunged, cancelled or removed in different circumstances – in all cases the term “expungement” will be used as a general term to describe each of the different scenarios. Grounds for expungement of a Trademark include:
- Cancellation of a trademark upon request by the registered proprietor of the trademark;
- Removal of the trademark from the register if the original registration was a wrongly made entry or if it remains in the register wrongly or because of an error or defect in any entry in the register;
- A trademark can also be removed by any interested person who applies for the removal if the proprietor of the trademark, or any person permitted to use the trademark fails to comply with any condition entered in the register in relation to its registration;
- If the trademark has fallen into non-use – whether it appears that there is no bona fide intention to use it or if it can be shown that, there is no bona fide actual use of the trademark for a continuous period of five years or longer. This must be shown up to three months before the application is made;
- Removal from the register is also possible on the ground of failure to record an assignment in the case where the proprietor of the trade has ceased to exist, a body (e.g. body corporate) has been dissolved, or if the proprietor was a natural person, where such person has died not less than two years prior to the application for removal;
- Removal of the register if (after due notice has been given to the proprietor of the trademark to affect the renewal, of the registration) the prescribed tim has expired and the renewal has still not been
- Revocation can be achieved through an application in the prescribed manner on specific grounds only:
- Where the Patentee is not a person entitled to apply for a patent;
- Where the grant of the patent is in fraud of the rights of the applicant or of any person under or through whom he or she claims;
- The invention concerned is not patentable under the requirements of the Patents Act;
- The invention, as it was set out in the complete specification concerned cannot be performed or does not lead to results and advantages as set out in the complete specification;
- The manner in which the invention is to be carried out by a person skilled to do so, is not fully described, ascertained and illustrated or exemplified (where necessary) in the complete specification of the patent
- Where claims of the complete specification of the invention are not clear or fairly based on the matter disclosed in the specification – this creates ambiguity and lack of fair basis and is in contravention of the requirements for an invention to be registered;
- The prescribed declaration lodged in respect of the application for the patent or the statement lodged in terms of the Act as required contains a false statement or representation which is material and which the patentee knew or ought to have reasonably known to be false at the time when the statement or representation
5. Are foreign patents and trademarks recognized and, if so, under what circumstances?PATENTS In cases where a patent application has been filed abroad, South African legislation state that the filing date in the country of first filing will provide the applicant or his successor in title, with the right to file a patent application in any number of contracting states within twelve months of the date of filing the first application. The later filed application will enjoy a priority status as if these later filed applications had been filed on the same date as the first application. The priority status includes:
- Applications for the same inventions filed after the first application;
- Events, which in the normal course would be novelty destroying, and which take place after the date of the first application;
- Same invention must form part of the first and alter filed applications;
- Capacity of the first application to serve as the basis for priority is not destroyed on abandonment, rejection or withdrawal thereof;
- Multiple and partial priority rights, as recognised by the Convention, allow the priority of several earlier applications, possibly relating to different aspect of the subject matter to be
- the applicant for registration in that country or his successor or assignee, may file an application for the same mark in South Africa within six months of the first application for that mark filed in the convention country;
- The application filed in South Africa will bear the same filing date as the convention date, with priority to all other applications;
- In terms of the Trademarks Act, the South African Registrar will not permit the South African application to cover any specification broader than the specification for which the convention application was originally filed, though a narrower specification may be covered;
- Partial priority applications cannot be filed in South Africa (as is the case in many other countries by virtue of a registry practice followed);
- Applications filed claiming Convention priority all required documentation must be lodged (together with an English translation where applicable) with the registry within three months from the filing of the South African
6. Are there any non- patent/trademark barriers to competition to protect medicines or devices?In many instances companies often apply for multiple patents on individual medicines over time in order to prolong their periods of patent protection. South Africa is a member of the World Trade Organisation (WTO) which set general standards of patent protection which all WTO members are required to provide under the Agreement on Trade-Related Aspects of Intellectual Property Rights – commonly known as the TRIPS agreement. South African Patent law provide for 20-year patent protection and under Trademark Legislation a Trademark is protected for and should be renewed every 10 years. Competition policy, in relation to patent granting, is more concerned with the questions whether the patent is warranted and necessary to achieve one of the means through which the patents system encourages innovation and whether a patent conveys market power. If the patent is not warranted and does not encourage innovation, a patent should not be granted as such a patent could impose costs on the public. The reasoning behind last mentioned suggests that the non-protection should then leave room for competition policy to spur innovation and provide consumers with what they want at optimal prices, quantity and quality. When taking this into consideration when determining whether a patent conveys market power, if an unwarranted patent confers market power on a patent-holder, it can deprive consumers of the benefits of competition without compensating value. When keeping in mind that the South African patent system does not investigate the merits of each invention or the patent, multiple patents in a single medicine could easily be granted for a 20-year period and for longer if a second patent is granted. Patent-protection is well-known as it is given for a set period, which is important for innovation, particularly of pharmaceutical companies as this presumably enables pharmaceuticals to sustain the prices of medicines, recoup research and development expenditure and finance the development of new products. Competition policy is seen as instrumental in ensuring access to medicines and ensuring medical technology and innovation in the pharmaceutical sector. International furore has been raised on whether pharmaceutical patents interfere with access to essential medicines in lower income countries. South Africa is signatory to the TRIPS agreement that commits itself to having certain patent laws in the country. This agreement introduced the minimum standards for protecting and enforcing intellectual property rights and requires WTO members to make patents “available for any inventions, whether products or processes, in all fields of technology”. This also includes patents for pharmaceutical processes and products. The TRIPS agreement has received some criticism over the years in so far the increased levels of patent protection of medicine prices are concerned. While TRIPS does offer safeguards to remedy the negative effects of patent protection or patent abuse, in practice it is unclear whether and how countries can make use of these safeguards when patents increasingly present barriers to medicine access. The Companies and Intellectual Properties Council is currently reviewing and involved in preliminary research on a potential move from a depository patent system to a substantive examination system. In the process it has considered several structural options of patent protection systems. There are some arguments against a substantive examination system where the fact that it will be costly and burdensome has been raised as a potential problem, as well as the fact that it requires an extensive human resource investment. With that being said, it has the potential to discourage foreign business which South Africa obviously want to avoid, as the aim is to encourage foreign business and investment into the South African economy.
7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?LIST OF EXCLUSIONS FROM PATENTABILITY Section 25 provides specific indication on what shall not be deemed an invention for the purposes of this Act. Anything which consist of:
- A discovery;
- A scientific theory;
- A mathematical method;
- A literary, dramatic, musical or artistic work or any other aesthetic creation
- A scheme, rule or method for performing a mental act, playing a game or doing business;
- A program for a computer;
- The presentation of
- Does not constitute a trademark in terms of Section 10(1);
- Is not capable of distinguishing within the meaning of section 9 of the Act (section 10(2)(a));
- Consists exclusively of a sign or indication which may serve, in trade, to designate the kind, quality, quantity, intended purpose, value, geographical origin or other characteristics of the goods or services (section 10(2)(b));
- A mark which consists exclusively of a sign or indication which has become customary in the current language or in the bona fide and established practices in the trade(section 10(2)(c));
- Is one in relation to which the applicant has no bona fide claim to proprietorship (section 10(3));
- The applicant has no bona fide intention of using as a trademark, either himself or through a person permitted by him to use the mark as contemplated in section 38 of the Act (section 10(4));
- Consists exclusively of the shape, configuration, colour or pattern of goods where such shape, is necessary to obtain a specific technical result, or results from the nature of the goods (section 10(5));
- Constitutes, or the essential part of which constitutes, a reproduction, imitation or translations of a well-known mark that is entitled to protection under the Paris Convention for the Protection of Industrial Property and is used on identical or similar goods; where use of the mark is likely to cause deception or confusion (section 10(6));
- Is the subject of an application for protection which was made mala fide (section 10(7)) ;
- Consists of or contains the national flag or the armorial bearing or any other State emblem of South Africa or of a convention country (section 10(8));
- A mark which contains any word, letter or device indicating State patronage (section 10(9));
- A mark which contains any word, letter or device indicating State patronage (section 10(10));
- Consists of a container for goods or the shape, configuration, colour or patent of goods, where the registration of such mark is likely to limit the development of any art or industry (section 10(11));
- Is inherently deceptive or the use of which would be likely to deceive or cause confusion, be contrary to law, be contra bonos mores, or be likely to give offence to any class of persons (section 10(12));
- As a result of the manner in which it has been used, would be likely to cause deception or confusion (section 10(13));
- Is identical to a registered trademark belonging to a different proprietor or so similar to the it that the use thereof in relation to goods or services in respect of which it is sought to be registered would be likely to deceive or cause confusion, unless the person making the earlier application consents to the registration of such mark (section 10(14));
- Is identical to a mark which is the subject of an earlier application by a different person, or so similar there to that the use thereof in relation to goods or services in respect of which it is sought to be registered and which are the same as or similar to the goods or services in respect of which the earlier application is made, would be likely to deceive or cause confusion, unless the person making the earlier application consents to the registration of such mark (section 10(15));
- Is the subject of an earlier application as contemplated in section 10(15) of the Act, if the registration of that mark is contrary to existing rights of the person making the later application for registration as contemplated in that paragraph (section 10(16));
- Is identical or similar to a trademark which is already registered and is well known in the Republic of South Africa, if the use of the mark sought to be registered would be likely to take unfair advantage of, or be detrimental to the distinctive character or the repute of the registered trademark, notwithstanding the absence of deception or confusion (section 10(17));
8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?TRADEMARKS A licence refers to the relationship between the proprietor of a trademark and the entity authorised by the proprietor to use that trademark in relation to goods manufactured and sold or in respect of the services rendered. In terms of Section 38 of the Trademarks Act, registration of a user of a mark shall be prima facie evidence that the use of the registered trademark by the user is permitted use as contemplated by section 38(1). The Trademark regulations confirm in regulation 39 that an application must be brought to the Registrar for the registration under section 38(6) of the Act for a person to be able to act as a registered user of a registered trademark and such application must be made by the registered proprietor on Form TM7 with the relevant accompanying documentation included. It can therefore be inferred that a trademark license agreement, whether it is with a foreign licensor or not, must be provided to the Registrar in order for the confirmation of approved usage to be on file and on record in South Africa. PATENTS A licence agreement in respect of a patent is an agreement in terms of which the licensor grants to the licensee exploitation rights in terms of the invention. The licence can take different forms such as an agreement in writing, oral agreement or tacit agreement. There are specific timelines involved in the recording of a licence against a patent – it must be made within six months of the event entitling the recording of such licence, or within six months of the grant of the patent. In cases where the licence agreement had been before such a grant, the Registrar may extend this time limit on application and on payment of the prescribed fee. There is no explicit indication that the licencing is affected by the fact that it is extended by a foreign licensor, nor is there direct indication that such licence is required to be registered against a patent. This is confirmed by the wording in Section 53 (1) of the Patents Act which state: “At any time after the date of the sealing of a patent, the patentee may apply (own emphasis) to the registrar for the patent to be endorsed with the words “licences of right” and where such an application is made the registrar shall, if satisfied that the patentee is not precluded by contract from granting licences under the patent, cause the patent to be endorsed accordingly.
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4. Product Liability: South Africa
1. What types of liability are recognized in your jurisdiction?In terms of South African common law legal liability may arise from a breach of contract or from delict. Liability in delict may arise irrespective of the existence of a contract between the producer and the injured party. Claims from breach of contract usually take the form of an action for breach of a warranty concerning the fitness of the product. Under common law contractual liability for a defective product rests on an express or implied warranty that the product is free from defects, or on a misrepresentation by the supplier regarding the qualities of the product (which are claimed or stated to be defect free). The rights of the purchaser are determined by the contract with the supplier of the contract and only parties to such contract derive rights and obligations from it – this is known as privity of contract, a doctrine which prevents out- siders to a contract from suing or being sued in terms of the contract.
2. How do these types of liabilities apply to the manufacturers of medicines and devices?Currently in South Africa there is no specific liability regarding pharmaceutical products. Rights of Consumers are however governed by the Consumer Protection Act No 68 of 2008 (the CPA) and in this regard in terms of Section 55 there is an implied warranty on any products, good or services rendered to a consumer. It should however be noted that in addition to an implied warranty of quality which applies ex lege to any transaction governed by the CPA, other provisions are also made in the Act pertaining to unsafe goods or a defect, hazard or failure in goods. The Consumer Protection Act does not provide for special rules in respect of pharmaceutical products. In this respect South Africa will follow most European jurisdictions, where arguments for special treatment of pharmaceutical products have generally not prevailed. There are however strict quality controls in place which apply to the manufacture, importation and distributions of prescription medicines. Most of these quality controls are involved in the monitoring of all stages of the different manufacturing and distribution processes (as would be required in terms of the Regulatory and Compliance requirements from the SAHPRA as well) and as such, contain risks effectively in most cases. It has been suggested that the application of various safety standards in terms of Section 61(1) of the CPA, read with Section 53(1), requires particular consideration of different factors such as:
- Whether the medicine or medical device has harmful effects which exceed the limits considered tolerable in light of the current medical knowledge and technological advancement; and
- The balance between the risks of harm and the therapeutic benefits of the medicine and/or medical device
3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?In terms of the South African Companies Act, Directors and prescribed officers can be held liable in specific circumstances as set out in Section 77 of the Act. The purpose of the Act includes the registration of offices of foreign companies carrying on business within the Republic and to define the relationship between companies and their respective shareholders or members and directors. Potential liability in terms of the CPA extends to any supplier, whether or not they reside in South Africa. Directors (which in terms of this Section, includes an alternate director, and a prescribed officer or a person who is a member of a committee or board of a company, or of the audit committee of a company, irrespective of whether or not the person is also a member of the company’s board) may be held liable in accordance with the principles of common law relating to breach of a fiduciary duty, for any loss, damages or costs sustained by the company as a consequence of any breach by the director of a duty as contemplated in the Act. A Director may also be held liable in accordance with principles of the common law relating to delict for any loss, damages or costs sustained by the company as a consequence of any breach by the director of a duty contemplated in the Act or breach of any provision of this Act not otherwise mentioned in Section 77 or any provision of the company’s Memorandum of Incorporation.
4. How can a liability claim be brought?Claiming for liability from a manufacturer or supplier will depend on the basis on which the claim is brought. If the claim is a result of a breach in the contractual relationship between parties, the law of contract provides several remedies for circumstances where harm was caused by defective products. In South Africa the delictual remedy provided by the common law is the Aquillian action, which is based on fault in cases where harm was caused. Section 61 of the Consumer Protection Act does however now provide a similar remedy – it discards fault and gives its own content to the concept of a defect, but it still incorporates elements of an action in delict, which include damages, causing harm. The defences such as prescription and consent can however also be used in opposing a claim in this regard. Common law liability exists as an alternative basis for recovery of damages for harm done by defective products and may remain relevant in the situation where the injured consumer is unable to meet the requirements as set out in the definitions contained in the Act. The CPA provide each consumer with means to enforce their rights by means of Section 69 which provides for the consumer to refer the matter directly to the Consumer Tribunal, if such a direct referral is permitted by the Act in the case of the particular dispute – there are prerequisites for such referral which is set out in the CPA under a different section. The consumer also has the right, in terms of Section 69 of the CPA, to: -
- refer the matter to the applicable ombud with jurisdiction, if the supplier is subject to the jurisdiction of any such ombud;
- if the matter does not concern a supplier who is subject to the jurisdiction of an ombud, the consumer has the right to refer the matter to the applicable industry ombud, accredited in terms of Section 82(6) of the CPA, if the supplier is subject to any such ombud;
- apply to the consumer court of the province with jurisdiction over the matter, if there is such a consumer court, subject to the law establishing or governing that consumer court;
- refer the matter to another alternative dispute resolution agent contemplated in section 70 of the same Act; or
- file a complaint with the Commission (in accordance with Section 71); or
- approach a court with jurisdiction over the matter, if all other remedies available to that person in terms of national legislation have been
5. What defenses are available?The claimant is only allowed to approach a court if all other remedies available to them in terms of national legislation have been exhausted. If the manufacturer is able to prove that this is not the case, the claimant will not be able to institute action in court. There are also limitations placed on the consumer’s right to bringing an application, one being that an application may not be referred or made to the Tribunal or to a consumer court more than three years after the act or omission that is the cause of the complaint or in the case of a course of conduct or continuing practice, the date that the conduct or practice ceased. A complaint in terms of this Act may not be referred to the Tribunal or to a consumer court in terms of this Act, against any person that is, or has been, a respondent in proceedings under another section of the CPA relating substantially to the same conduct. A manufacturer can make use of Section 115(2) of the CPA as a defence when a claimant has instituted civil action in contravention of this section which indicate that a person who has suffered loss or damage as a result of prohibited conduct, or dereliction of required conduct may not institute a claim in a civil court for the assessment of the amount or awarding of damages if that person has consented to an award of damages in a consent order.
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5. Traditional Medicines & OTC Products: South Africa
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?In terms of the Medicines Act medication is classified into 4 categories from Category A- Category D depending on the In terms of the Act, “Complimentary medicines” means any substance or mixture of substances that -
- Originate from plants, fungi, algae, seaweeds, lichens, minerals, animals or other substances as determined by the Authority;
- Is used or purporting to be suitable for use or manufactured or sold for use –
- In maintaining, complementing or assisting the physical or mental state; or
- To diagnose, treat, mitigate, modify, alleviate or prevent disease or illness or they symptoms or signs thereof or abnormal physical or mental state of a human being or animal; and
- Is used –
- As a health supplement
- In accordance with those disciplines as determined by the Council
- Is declared by the Minister, on recommendation by the Council, by notice in the Gazette to be a complementary
- A mixture of substances of different discipline-specific origins or philosophies;
- A mixture of at least one substance of discipline-specific origin;
- A mixture of at least one substance of discipline-specific origin and one more of its isolated constituents.
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?Under the General Regulations relating to medicines, complementary medicines may only be advertised through a statement identifying the discipline of the medicine where relevant and an indication that the medicine must be used in accordance with the applicable complementary discipline and principles where relevant. It must also be stated whether the medicine has not received registration with the Authority and if so, the following disclaimer must be present when advertising is done: “this unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use”. Direct advertisement to the public thus in this regard must adhere to the above requirement and must be clear, direct and factual – no misleading or vague statements about the product can be made.
3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?According to the SAHPRA guideline on Complementary Medicines – Discipline-specific Safety and Efficacy, any advertisement or marketing claims for complementary medicine must adhere to specific requirements. An important aspect of this is that the claims made must not cause any member of the public to become anxious or stressed or have the effect that unnecessary concern about their health is created through the advertisement or marketing claims made for the relevant product. In general, and unless specifically pre-approved as a disease risk reduction claim, indications that refer (explicitly or implied) to the treatment, or cure of specific disease are not suitable for use for health supplements. The following disclaimer must appear on the immediate (as appropriate) and outer container label: “Health supplements are intended only to complement health or supplement the diet”. Reference to the relative Nutritional Reference Value as a percentage may also be included on the label where relevant. Any use of artificial sweeteners must be clearly stated as in the Guideline: Complementary medicines: Registration Application ZA-CTD – Quality. The General Regulations under the Medicines Act further state that Schedule 0 and Schedule 1 medicines may be advertised to the public directly. From Schedule 2 through to Schedule advertising of the medication may only be done to Medical practitioners, Dentists, Veterinarians, Pharmacists and other persons authorised to prescribe medicines, Persons in receipt of certain publications containing the advertising.
4. What are the regulatory requirements for over-the-counter (non-prescription) medications?The SAHPRA determine the categories of medicines – the primary method in doing so is based on a Schedule system which is determined from Schedule 0 to Schedule 7. Each Schedule is applied taking into account the various conditions which is attached to the distribution and sale of the medicine depending on the nature of the schedule that is applied. In this regard Schedule 0 medicines are available off the shelf or without prescription in a supermarket. This includes the complementary medicines with a Schedule 0 category, as the same rules apply though they are still required by law to now apply for registration and adhere to the regulatory requirements as set out by the SAHPRA. In terms of South African Regulations Schedule 1 and Schedule 2 medicines are available without prescription, but only from a pharmacist. They are referred to as “over the counter medicines” (OTC). In the case of health supplements and complementary medicines which contain scheduled substances, it becomes an allopathic medicine which falls into the above categories. In this instance, when considering health supplements and complementary medicines, most will be schedule 0, or has the potential to fall into a category which will be in the general market but has not yet been determined.
5. Are there any limitations on locations or channels through which OTC products may be sold?Schedule 0 medicines are available at supermarkets and other retail outlets and do not require the involvement of a pharmacist or other professional at all. These medicines may be sold by anyone and to anyone – which is why they are referred to as “over-the-counter” medicines. They must still be manufactured under controlled conditions in accordance with the Good Manufacturing Practice standards of the SAHPRA. Schedule 1 medicines are made available only from pharmacies and may be sold only by a pharmacist or a pharmacist intern or pharmacist’s assistant under the supervision of a pharmacist. This Schedule medication should not be on an open shelf in a pharmacy. Schedule 2 medication can be bought without a prescription from a medical practitioner and is considered within the South African context to be “pharmacist prescription medicines”. Only someone entitled to sell these medications (such as a pharmacist or a holder of a dispensing licence) may own Schedule 2 medicines for the purpose of sale.
6. What health, advertising, and marketing claims may be made for OTC products?It is important that the presentation of OTC products must not be misleading or confusing as to the content of the content and proper use of the medicines. For purposes of making clear statements, the information provided must always include the correct information regarding which ingredients, components or characteristics the OTC product has. The name of the product must not be the same as the name applied to other products that are already supplied in South Africa. In addition to last mentioned, the label of the product must declare the presence of a therapeutically active ingredient and the presentation of the product must always indicate safe use of the product. The purpose and intended use of the product must always be explained to an extent which the consumer/patient/end-user will understand. Generally, advertisements must not be misleading or disparaging (whether done directly or by implication) and claims and comparisons must be fair, balanced, objective, accurate, unambiguous and supportable – in this regard it is important that the advertisement is based on up-to-date reflections of evidence evaluated, and such evidence must be reflected clearly. Use of any terminology (medical or related) is not unacceptable; the consumer must just not be misled or confused by its inclusion.
7. Can OTC products be marketed or advertised directly to the public?Only if the OTC product is registered as a Schedule 0 medications in terms of the Medicines Act.
8. What is the mechanism by which a prescription-only product can be converted to an OTC product?Prescription-only medication will only be able to be converted to an OTC product if the composition of the medicine is changed to the extent that it becomes a Schedule 0, Schedule 1 or Schedule 2 medicine – which is available without prescription. It must be remembered that a distinction is made between a Medicinal substance and a Medicinal product whereby last mentioned is known by both their proprietary (brand name) and by the non-proprietary (generic, scientific or “approved”) names of their active ingredients. Medicinal products are per sé not listed in the Schedules to the Medicines Act. The Scheduling status of medicinal products depends upon the Scheduling status of their active ingredients. Thus, if the prescription-only product contains any active ingredient which falls within a Schedule 3 to Schedule 6 medicine, it will not be able to be converted to an OTC product. Such mechanism is not available under these circumstances.
9. What are the requirements for the importation of either traditional medicines or OTC products?A licence to Import/Export medicines is required in order for any medication to enter or exit the country. This is set out in Section 22C (1) (b) of the Medicines Act and includes the requirement that an application must be made in the prescribed manner. No person is allowed to import or export any medicine unless they are the holder of a licence as contemplated in the above-mentioned Section of the Medicines Act. The relevant licence to Import or Export medicines will be issued by the Regulator after due application and such a licence will be valid for a period of five (5) years from the date of issue. Since traditional medicines and OTC products are also regulated under complementary medicines, they must be imported as per the requirements contained in the Medicines Act and as set out in the guidelines of the SAHPRA.
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6. Marketing, Manufacturing, Packaging & Labelling, Advertising: South Africa
1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?MARKETING OF MEDICINES AND MEDICAL DEVICES OR IVDS: Marketing of medicines are regulated by Section 18 of the Medicines Act. Section 18(2) state “no person shall advertise any medicine or Scheduled substance, medical device or IVDS for sale unless such advertisement complies with the prescribed requirements” Section 18C of the Medicines Act further confirm that Marketing of medicines, medical devices or IVDs must be done in accordance with the relevant Regulations under this Act. Regulation 42 of the General Regulations for medicines under the Act, confirm that Schedule 0 medications may be advertised to the public. Medications containing substances listed as Schedule 2, Schedule 3, Schedule 4, Schedule 5 or Schedule 6 may be advertised under specific circumstances and to specific persons only. This includes pharmacists, medical practitioners, dentists, veterinarians, practitioners and other authorised prescribers or the information should be included in a publication which is normally only available to these persons. Advertisements of medications are also not allowed if it contains a statement which deviates from, is in conflict with or goes beyond the evidence submitted in the application for registration of such medicine with regards to its safety, quality or efficacy. Importantly the regulation of advertising for medical devices and IVDs are controlled by the Regulations relating to Medical Devices and IN VITRO diagnostic medical devices (IVDs). Regulation 21 and 22 under the Act provides for the advertising and labelling of medical devices and IVDs. In so far as the classification system applies to medical devices or IVDs in the South African legislative and Regulatory framework, only class A and class B medical devices and IVDs may be advertised to the public or a lay person. Class C or class D medical devices or IVDs, when advertised for the first time to a prospective user, must include written instructions on how to use the product. After this initial advertising in writing, at subsequent occasions, the information need only be available on request. LABELLING OF MEDICINES AND MEDICAL DEVICES OR IVDS: Regulation 10 of the General Regulations for medicines under the Medicines Act state that the immediate container of every medicine in which a medicine intended for administration to or use by humans must have a label attached to it with specific particulars included. Where this requirement applies to medical devices and IVDs, Regulation 22 of the Regulations relating to Medical Devices and IVDs under the Act state that the label of each medical device or IVD must contain specific information which include but is not limited to the trade name of the medical device or IVD, product description and the intended use, in cases where there is an incorporation of a medicine or biological substance with the medical device, it should be stated and either an expiry date or a date of manufacture must be present, whichever is possible and/or applicable. There are many requirements in this regard, which can be found in the regulation under discussion. One further important requirement with regards to the label of a medical device or IVD is that the label must at least be in English and must be
- On the medical device itself;
- On the packaging of each unit; and
- On the packaging of multiple medical devices or IVDs
2. What is the authorization process for the marketing of generic versions of these products?There is no formal process (such as an application for example) to follow with regards to marketing the generic product, as long as the advertisement and marketing of the product adhere to the requirements as set out in the respective regulations under the Medicines Act. The marketing of any medicine or medical device and IVD is regulated in terms of Section 18C of the Medicines Act and regulated by Regulation 42 of the General Regulations under the Act (for medicines) and Regulation 22 of the Regulations relating to medical devices and IVDs. For example, in terms of Regulation 22, only Class A and Class B medical devices and IVDs may be advertised to the public or lay person. If advertisement of a product which falls within Class C or Class D medical device or IVD is thus made to the public, it will be in contravention of this regulation and an offense in terms of the Medicines Act, which include penalties for misconduct.
3. What are the typical fees for marketing approval?The fees for marketing approval differ depending on the application made. An application for a New Chemical Entity (brand new medication never registered before and which is different from a vaccine) is ZAR 49 000, 00 as per the Government Gazette No 39154 published on 1 September 2015. Application for the registration of Generic Products (which include pharmaceutical, analytical and bioavailability evaluated) is ZAR 27 000, 00 per application. If the Generic Product has clinical data, the cost is ZAR 44 000, 00 per application. Many different fee allocations are available in this document depending on which type of application is made and this information is available in the public domain.
4. What is the period of authorization and the renewal process?The process of authorisation of a new and/or generic medication is not specifically defined in the Medicines Act. The application form has a specific entry area where you indicate whether the application is for registration of a new or generic medication. Regulation 45 of the General Regulations for medicines under the Act provides information on the time frames for considering applications by the Regulatory Authority. No specific timeline is provided, and the wording indicates that the Authority “shall as soon as practically possible and in accordance with a timeframe as determined by the Authority, inform any applicant of the receipt of an application for the registration of a medicine, medical device and IVD.” The acceptance of such an application will be acknowledged by the Authority “as soon as practically possible and in accordance with a timeframe as determined by the Authority after receipt of the application by the Authority”.
5. What are the requirements, if any, for post-approval pharmacovigilance?There are two SAHPRA guidelines which apply to post-approval pharmacovigilance:
- Recall, Adverse Event and Post-Marketing Vigilance Reporting of Medical Devices and IVDs; and
- Post-Marketing Reporting of Adverse Drug Reactions to Human Medicines in South Africa.
- The authorised representative or holder of a registration certificate must inform the Council of a suspected Adverse Event which was reported to him/her and which occurred as a result of usage of the medical device or IVD;
- There are specific timeframes within which such reporting has to take place, this is determined by the Council;
- The steps to be taken to address the adverse event which was reported, must be provided to the Council within the correct timeframe and conduct a concise critical analysis of the safety and performance of the medical device or IVD – the results must then be submitted to the Council.
- An identifiable source (reporter) of the information;
- Suspected medicine(s); and
- Suspected reactions.
- Establishment and maintenance of a system which ensure that information about all suspected adverse reactions which are reported (including to all medical representatives and clinical research associates), must be collect- ed and collated as it has to be accessible at a single point;
- This person must also the contact person to SAHPRA and the National Adverse Drug Event Monitoring Centre;
- Adverse drug reaction reports, summary evaluation statements of non-serious adverse drug reports occurring in South Africa and periodic safety update reports when necessary are also required;
- Ensuring that any request from SAHRA for additional information deemed necessary for the evaluation of the risk-benefit ration of a medicine, is provided to SAHPRA promptly and in accordance with all requirements.
6. Are foreign marketing authorizations recognized?Foreign marketing authorisations are not automatically recognised in South Africa, they are however taken into consideration during the application process. The application form for registration of a medicine includes as part of the required information under Part1D – Foreign Registration the following requirements:
- A list of countries in which an application has been lodged and the status of these applications shall be furnished, detailing approvals, deferrals, withdrawals and rejections;
- If the medicine has been registered by the regulatory authorities with which Council aligns itself, e. USA (FDA), European Union (EMEA), UK (MHRA), Sweden (MPA), Canada (Health Canada), Australia (TGA), and Japan (MWH), the following must further be included:
- a copy of the certificate of registration;
- the conditions of registration; and
- the approved package insert (data sheet) translated into English where relevant.
- Details of any negative decision by any regulatory authority reflected in the required documentation from the other regulatory authorities must also be provided as part of the
7. Are parallel imports of medicines or devices allowed?Parallel imports of medicines and devices are allowed and the industry is guided in this regard by the SAHPRA Guideline on Parallel Importation of Medicines in South Africa. Provisions on the Medicines Act with regards to Parallel importation in terms of Section 15C provide the means through which already patented medication which is registered in other jurisdictions can be brought into South Arica. This Section has to date not been used. In terms of the guideline the key objective in allowing parallel importation is to address the issue surrounding escalating costs of services, facilities and medicines. Parallel importation allows for the importation and registration of medicines which are under patent, are already registered in South Africa, and which originate from any site of manufacture approved by SAHPRA, regard- less of any existing patent rights. The Minister of Health is given the authority by the Medicines Act, to pro- cure a cost-effective or less expensive medicine than one already registered and available in the Republic. This is done by the Minister who allows the importation of the same medicine manufactured by, or on behalf of the approved manufacturer from any other country and the restrictions imposed by the Patent Act shall not apply. Certain conditions for Parallel Importation apply and must be adhered to in order for the relevant permit to be obtained. Once of which includes that the medicine must be patented and must already be registered in South Africa. In so far the rights of the Holder of the Certificate of Registration goes, they shall not be entitled to prevent the importation of the medicine into South Africa, nor its sale on account of such registration or on account of the existence of a patent on such a medicine. Any company or person that wishes to import a patented medicine must apply to the Minister of Health for a permit to parallel import a medicine. The parallel importer carries the responsibility and is liable for the parallel imported medicines in the event that an adverse event occurs for example, and they must notify the SAHPRA of this. The destruction of any expired, parallel imported medicines still remaining in stock after the expiry date, is the responsibility of the Parallel importer, whether during the duration of the permit or after the parallel importation permit has expired.
8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?The Health Professions Council of South Africa (HPCSA) is the Authority which regulates the medical professions and the practice of other specific health care practitioners such as physiotherapists and psychologists. The HPCSA acts in accordance with the Health Professions Act 56 of 1974 and the regulations under this Act. The HPCSA also publish guidelines to ensure compliance with the legislative requirements and to provide guidance to the practitioners on specific topics. Booklet 11 of the HPCSA Guidelines on Overservicing, Perverse Incentives and Related matters confirm that healthcare practitioners (this includes clinical researchers and Primary Investigators because they are medical practitioners) are not allowed to accept commission or any financial gain or other valuable consideration from any person or body or service in return for the purchase, sale or supply of any goods, substances or materials used by the healthcare professional in his or her practice. In terms of Rule 7 of the General Ethical and Professional Rules of the Health Professions Council of South Africa (Booklet 2), a practitioner shall also not offer or accept any payment, benefit or material consideration (monetary or otherwise) which is calculated to induce him or her to act or not to act in a particular way not scientifically, professionally or medically indicated or to under-service, over-service or over-charge patients.
9. How is the manufacturing of medicines and devices regulated and by which agencies?The Manufacturing of medicines, medical devices and IVDs is regulated by SAHPRA. There are 2 different Guidelines which deal with the specific requirements in this regard. The Guide to Good Manufacturing Practice (GMP) for medicines in South Africa indicate that manufacturing formulations and processing instructions should exist for each product and batch size to be manufactured. According to the latest version of this document, SAHPRA is a participating authority of the Pharmaceutical Inspection Cooperation Scheme (jointly known as PIC/S). The aim of PIC/S is to develop international standards between countries and pharmaceutical inspection authorities to provide harmonised and constructive cooperation in the field of GMP. Section 35 of the Medicines Act and Regulation 23 of the General Regulations in accordance with it, specify that any person/company who hold a licence to manufacture, import, export, be a wholesaler and/or distributor of medicines and related substances, must have the ability to comply with good manufacturing, wholesaling or distribution practices as determined by the Authority. This allows the Authority to determine manufacturing practices and the relevant code of GMP to be applied by manufacturers. To be noted that there are separate Regulations under the Medicines Act which deal with medicines and medical devices and IVDs, this is discussed and explained throughout this document. The regulations regarding medical devices and IVDs define manufacture as “operations that include the design, purchasing of material, specification, development, production, fabrication, assembly, processing, reprocessing, releasing, packaging, repackaging, labelling, and refurbishing of a medical device or IVD, as the case may be, and includes putting a collection of medical devices or IVDs, and possibly other products, together for a medical purpose in accordance with quality assurance and related controls.” Medical devices placed on the market require a Conformity Assessment as per SAHPRA’s Guideline on Conformity Assessment Procedures for Medical devices and IVDs. This Guideline confirms that the Conformity Assessment is primarily the responsibility of the manufacturer. For devices sold in South Africa – the assessment is undertaken in the context of the South African regulatory requirements and both the process and conclusions may be subject to further review by the Council and/or the Conformity Assessment Body accredited by the South African National Accreditation System (SANAS).
10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the US Food & Drug Administration (US FDA) and/or the European Medicines Agency (EMA)?The guideline on Good Manufacturing Practice for Medicines indicate that GMP agreements with competent international regulatory authorities are deemed to support information sharing and other desirable objectives for international regulatory collaboration. The regulatory standards in South Africa have been robust, thorough and in line with international best practices. SAHPRA is a member of various international medicines initiatives that includes the FDA and EMA. SAHPRA also signed a memorandum of understanding with the FDA and SwissMedic (Swiss Regulator) to allow exchange of information. SAHPRA aligns itself with regulatory authorities which are members of the International Conference on Harmonization of Technical requirements for Registration of pharmaceuticals for Human use (ICH) such as the FDA. It further aligns with ICH observers such as Swiss-medic and Health Canada and also aligns itself in cases where a regulatory authority associated with an ICH regulatory authority member through a legally binding mutual recognition agreement such as TGA in Australia, Norway, Iceland and Liechtenstein. The aim with these alignments and associations are to ensure that local manufacturing requirements are of excellent standard and compatible with GMP requirements on and international level.
11. What is the inspection regime for manufacturing facilities?Different quality control processes must be in place and implemented accordingly to ensure the manufacturing facilities are in line with the required standards as set out by the Regulatory Authority Self-inspection is included in the SAHPRA guideline on Good Manufacturing Processes, whereby it is indicated that self-inspection must be conducted in order to monitor the implementation and compliance with GMP principles and to propose necessary corrective measures. All self-inspections should be conducted in an independent and detailed manner at intervals following a pre-arranged programme in order to verify their conformity with the principles of Quality Assurance. The Medicines Act also specifies the appointment and role of Inspectors in Sections 26 and 28. The Directorate: Inspectorate and Law Enforcement carry out regular and repeated inspection of manufacturing sites both in South Africa and in Countries with which SAHPRA does not have a Mutual Recognition Agreement. Inspection enables the Inspectorate to confirm that licence holders are complying with the conditions of their licence, with the provision of the Medicines Act and with GMP. According to the SAHPRA Guideline on Licence to Manufacture, Import or Export, Inspectors are empowered to (amongst other things):
- enter any place or premises from which:
- The holder of a licence to manufacture, import or export conducts business;
- The holder of a certificate of registration of a medicine conducts
- inspect the premises used in the manufacture, packing, testing storage and distribution of medicinal products; and
- take samples; and
- seize any book, record, documentation or medicine or scheduled
12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?This is not currently specified in the guidelines or the Act, the only confirmed information relates to Inspectors with authority as provided to them by the CEO of the South African Authority – from an interpretation of the relevant Section and regulations under the act it can be inferred that this authority is extended to Inspectors from within the South African Regulatory framework only. However, there is no formal restriction on approaching the SAHPRA with a request for such allowance depending on the circumstances surrounding such request.
13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?Storage of medical devices and medicines are very important since good practice requires that wholesalers maintain storage areas within temperature limits appropriate for the product concerned and that temperatures are monitored regularly to demonstrate that specified storage conditions are met. It is also important that medical devices and IVDs are not subjected to adverse temperatures during delivery from warehouse to customer or user. A wide variety of cold storage units are available, ranging from domestic refrigerators to large, custom-built, walk-in cold rooms. Whichever type of unit is used, it must be capable of maintaining all parts of the load within the range specified for the medicines concerned, which for products requirement cold storage is normally 2-8 degrees Celsius. The type of temperature monitoring device used should be suitable for the type and size of the unit. As a guide, small units should be checked and recorded at least daily using a manual or electronic max./min. thermometer. Larger and walk-in units should be fitted with a continuous recording device such as a chart recorder, or a device that provides regular printouts of actual temperatures. These records should be checked at least daily and the checks should be recorded, e.g. by annotating the chart/printout. Measuring and recording devices should be calibrated regularly. Temperature monitoring is a very important and essential part of the handling and distribution process and should be done in accordance with all the relevant regulations, rules and industry guidelines. Packaging of medicines, medical devices and IVDs fall under the definition of “manufacturer” which means “all operations including purchasing of material, processing, production, packaging, releasing, storage and shipment of medicines and related substances in accordance with quality assurance and related controls”. It is also the responsibility of the Responsible Pharmacist for the manufacturer or relevant licence holder, to safeguard the product users against potential hazards arising from poor distributions practices – as a result, for example of supplying suspect products and poor storage, amongst other things. The manufacturer has obligations with regards to the licence held as provided by the Regulatory Authority. These include, but are not limited to the storage, packaging and handling of medicines, medical devices and IVDs.
14. What information must be included in medicine and device labeling?There are several specific requirements with regards to what must be included in the labels of medicines, medical devices and IVDs. Section 18 of the Medicines Act confirm that medication, medical devices and IVDs may only be sold if the immediate container or the package in which that medicine (or Scheduled medicine) is sold, bears a label stating the prescribed particulars and in the case of medical devices and IVDs, the medical device or IVD itself or its packaging must bear a label, where practical, stating the prescribed particulars. The labelling of medical devices or IVDs is specifically regulated by Regulation 22 of the Regulations relating to medical devices and IVDs under the Act. According to this regulation certain information must be included on the label and include but is not limited to:
- The name or trade name of each medical device or IVD;
- Product description and intended use;
- A product catalogue code, where applicable;
- The name and business address of the manufacturer;
- The name and business address of the holder of the manufacturer;
- Where appropriate, an indication that the medical device contains or incorporates a scheduled or biological substance;
- For accessories, the serial number may be substituted with a control number and for software it may be substituted with a version number;
- The expiry date where applicable;
- Where there is no expiry date, the manufacturing date;
- Where relevant, an indication of the net quantity of content, expressed in terms of weight or volume, numerical count, or any combination of these or other terms which accurately reflect the contents of the package;
- Warnings or precautions, where applicable;
- Where appropriate an indication that the medical device is intended for single
- A medicine containing any Scheduled substance, must have the letter “S” followed by the number of the relevant Schedule, in a prominent typeface and size and surrounded by a square border, immediately preceding the proprietary name of such medicine;
- The proprietary name of the medicine;
- The registration number of the medicine allocated in terms of section 15(5) of the Act;
- Application number allocated by the Authority followed by the expression “Act 101/1965”;
- Dosage form of the medicine;
- The approved name of each active ingredient of the medicine and the quantity thereof contained in a dosage unit, or per suitable mass or volume or unit, ranked according to the active ingredients with the highest schedule, in lettering which has minimum legibility: provided that labelling of medicines in solutions for injections must identify the active ingredient in terms of the active component per unit volume of solution;
- The name and percentage of any bacteriostatic or bactericidal agent which has been added to the medicine as a preservative;
- The approved name of any anti-oxidant contained in the medicine;
- The content of the medicine package expressed in the appropriate unit or volume of the medicine;
- Approved indications where practical, for use of the medicine;
- The recommended dosage of the medicine, where practical;
- In the case of a medicine intended for injection by a particular route of administration only, that route of administration by means of suitable words or abbreviations.
15. What additional information may be included in labeling and packaging?Where medicine is concerned, the name and address of the manufacturer of the medicine, the date of manufacture of the medicine or the scheduling status and registration number allocated by another national medicines regulatory authority of a country as determined by the Authority; provided that this information is surrounded by a square border including the name of the reference country. There are extra rules that apply where a medicine bears both an immediate container label and an outer label, which requirements are contained in Regulation 10(3) of the General Regulations under the Act. Where Medical Devices and IVDs are concerned, if the medical device is reprocessed, the label must state the name of the re-processor and identify the medical device as a reprocessed one. If an IVD kit includes for example, individual reagents and articles that may be made available as separate IVD medical devices, they must comply with the requirements set out in sub-regulation (1) of the General Regulations under the Medicines Act.
16. What items may not be included in labeling and packaging?Importantly labelling and packaging link directly with the marketing of a product and in terms of Regulation 21 of the Regulations for medical devices and IVDs, no advertisement for a medical device or IVD may contain a statement which deviates from, is in conflict with or goes beyond the evidence submitted in the application for registration of the medical device or IVD with regard to its safety, quality, or performance where the evidence has been accepted by Council and incorporated into the approved instructions for use. This means that the label and package of the medical device or IVD must not include any information that is in contravention of the information which was included in the original application to the Regulatory Authority when the initial request for registration of the product was made. The same principle applies in terms of Regulation 41(4) of the General Regulations under the Act which deal with Medicines.
17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?
- Only Class A and Class B (the lower risk) medical devices and IVDs may be advertised to the public
- An advertisement for a medical device or IVD may not contain a statement which deviates from, is in conflict with or goes beyond the evidence submitted in the application for registration of the medical device or IVD with regard to its safety, quality or performance where the evidence has been provided to and accepted by the council and incorporated into the approved i instructions for use of the medical device or
- A written advertisement for a medical device or IVD must contain the name of the medical device or IVD and in the case of a registered medical device or IVD, the registration number allocated to the medical device or
- Class C and Class D medical devices or IVDs, when advertised for the first time to a prospective user, written information, which must include at least the information referred to in regulation 23 or regulation 24 of the Regulations for medical devices and IVDs, must simultaneously be given to the person to whom the oral, electronic or printed advertisement is directed and;
- When the medical device or IVD is advertised on subsequent occasions, the information must be available on
- Medicines which contain Schedule 0 substances or a substance listed as Schedule 1 may be advertised to the public;
- Medicines which contain Schedule 2, Schedule 3, Schedule 4, Schedule 5 or Schedule 6 may be advertised in the following circumstances:
- Only for the information of pharmacists, medical practitioners, dentists, veterinarians, practitioners, and other authorised prescribers; or
- In a publication which is normally or only made available to person referred to in
- Despite the requirement that medicines above Schedule 2 may only be advertised in the circumstances as discussed above, it should not be construed as to prohibit informing the public of the prices, names, pack sizes and strengths of medicines which contain a substance appearing in Schedule 2, Schedule 3, Schedule 4, Schedule 5 or Schedule 6 provided that no reference inference is made to the registered indications;
- No advertisement of a medicine may contain a statement which deviates from, is in conflict with or goes beyond the evidence submitted in the application for registration of such medicine with regards to its safety, quality or efficacy where such evidence has been accepted by the Authority in respect of such medicine and incorporated into the approved professional information of such medicine;
- An advertisement for such medicine shall contain the proprietary name and where there is a written advertisement, the approved name and quantity of each active ingredient of such medicine in lettering having minimum legibility, in the case of a registered medicine, the registration number allocated to it in terms of Section 15(5) of the Act; and
- If a medicine was submitted for registration in terms of Section 14 of the Act, the reference number allocated to the application, followed by the words “Act 101/1965”; and
- If any other name than the proprietary name is used, such other name shall be in lettering one half the size of the largest type size in which the proprietary name appears in such advertisement; and
- Where the medication is veterinary medicine, it must be indicated as such; and
- In the case of complementary medicine, a statement must be included identifying the discipline of the medicine where relevant and an indication that the medicine must be used in accordance with the applicable complementary discipline and principles where If the medication has not received registration with the Authority yet, the following disclaimer must be used “This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use”; and
- Where a medicine contains more than one active ingredient, no specific reference shall be made to the specific properties of any individual active ingredient unless a reference of this nature has been approved by the Authority for inclusion in the professional information of such medicine; and
- Verbal advertisements for the first time to pharmacists, medical practitioners, dentists, veterinarians, practitioners, and other authorised prescribers, written information must be included, containing at least information which refers to professional information for medicines for human and veterinary medicines
18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?In order to be able to sell medicines in South Africa, the relevant licence applicable to all activities must be applied for and obtained from SAHPRA. In terms of Section 22(1) (C) a person or company must be in possession of a licence to dispense or to compound medication and dispense it. It is also required that the manufacturer or person importing/exporting or distributing the medicine, must have a licence to act as a wholesaler of the product as well. In this regard Regulation 23 of the General Regulations under the Act state that the applicant for such licence must specify the medicines or Scheduled substance to be manufactured, imported, exported or distributed and sold. Section 22(6) of the Act clearly indicate that no one is allowed to manufacture, act as wholesaler of or distribute, as the case may be, any medicine, Scheduled substance, medical device or IVD unless he/she is the holder of a licence to manufacture, distribute or act as wholesaler of or to import or export. It is therefore inferred that the sale and delivery of medicines via post is unlikely given the strict requirements regarding the distribution and whole- sale practices in this regard. This also link with the requirements set out in the legislation regarding dispensing of medicines.
19. What are the restrictions and requirements for electronic marketing and advertising via email, by internet, social media, and other channels?With regards to Professional information for medicines for human use, information may be provided (and this includes advertisements) in electronic format provided that the manner in which the professional information may be accessed is stated on the patient information leaflet as contemplated in regulation 12(2) (b) of the General Regulations under the Act. The information provided may also be provided in any of the other official languages and in any other format to enable its accessibility for persons living with disabilities. In so far electronic marketing of medical devices and IVDs are concerned, Regulation 21(e) (i) of the Regulations relating to Medical devices and IVDs confirm that it is allowed, but in such instances, with regards to a Class C and Class D medical device or IVD specifically, written information must be provided to the person to whom the product is being advertised, simultaneously with the oral, electronic or printed advertisement.
20. May medicines and devices be advertised or sold directly to consumers?The licence to act as a distributor and wholesaler of a medical device or IVD or for a medicine is provided by the Regulatory Authority on an application and approval basis.
MEDICAL DEVICES AND IVDSOnly Class A (low risk) and Class B (low to moderate risk) medical devices and IVDs may be advertised directly to the public or a lay person. Class C (moderate to high risk) and Class D (high risk) medical devices are only allowed to be advertised to pharmacists, medical practitioners, dentists, veterinarians, practitioners, and other authorised prescribers. A wholesaler purchases medical devices or IVDs from a manufacturer or distributor and sells them into the retail sector. All procuring, holding, supplying or exporting of medical devices and IVDs, apart from supplying medical devices and IVDS to the public, are wholesale activities.
MEDICINESMedicines which contain Schedule 0 or Schedule 1 substances may be advertised to the public. Medicines which contains substances listed as Schedule 2, Schedule 3, Schedule 4, Schedule 5 and Schedule 6, may be advertised only for the information of pharmacists, medical practitioners, dentists, veterinarians, practitioners, and other authorised prescribers. However, the public may be informed of the prices, names, pack sizes and strengths of medicines which contain a substance appearing in Schedule 2, Schedule 3, Schedule 4, Schedule 5 or Schedule 6 provided that no reference or inference is made to the registered indication. The definition of “wholesaler” as contained in the SAHPRA guideline is “a dealer or trader who acquires any medicine or medical device from a manufacturer and sells or distributes it to the retail sector and includes wholesale pharmacy.” It can thus be inferred that a wholesaler cannot sell medicine directly to consumers; they are allowed to sell to the retail sector and wholesale pharmacies, who then go on to sell the product to the consumers.
21. How is compliance monitored?The requirements with regards to Labelling and Advertising of Medicines, Medical devices and IVDs are set out in Section 18 of the Medicines Act.
MEDICAL DEVICES AND IVDSRegulation 21 of the Regulations relating to medical devices and IVDs under the Act, specify the requirements for advertising for these products. Compliance to the Regulations and the requirements in this regard is contained in Regulation 20 which confirm that medical devices and IVDs must conform to the standards and specifications which were furnished to the Council on the relevant form when the initial application for registration or licencing was done and which was then accepted by Council in respect of the medical device or IVD. There must also be compliance in the form of conforming to the Essential Principles furnished to the Council with a declaration of conformity. Any proposed deviation from accepted standards and specifications referred to in the Regulations under the Act, must be submitted to the Council for prior approval. MEDICINES Regulation 42 of the General Regulations under the Act provides the specific requirements with regards to the Advertising of medicines and compliance with this Section. Regulation 53 of the General Regulations which relate to medicines also confirm that compliance with the standards and specifications which were furnished to the authority must be ensured and adhered to. In monitoring both the medicines and medical device and IVDs, the Regulatory Authority can send out Inspectors to investigate the premises, manufacturing, distribution, importing, exporting and wholesale activities of an applicant or licence holder, at any given time.
22. What are the potential penalties for noncompliance?MEDICAL DEVICES AND IVDS The Offences and Penalties should the requirement for Advertising not be adhered to include that the person/entity/company who is non-compliant, is guilty of an offence and upon conviction is liable to a fine, or to imprisonment for a period not exceeding 10 years. Further to the above, a person who sells a medical device or IVD that has expired is guilty of an offence and upon conviction is liable to a fine, or to imprisonment for a period not exceeding 10 years.
MEDICINESRegulation 52 confirm that any person who fails to comply with, contravenes the provisions of or furnishes incorrect information, as the case may be in respect of amongst others, Regulation 42, shall be guilty of an offence and upon conviction be liable to a fine or to imprisonment for a period not exceeding 10 years.
Also from this Legal Handbook
7. Preclinical & Clinical Trial Requirements: South Africa
1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?No. Clinical Trials do not have to be conducted locally in order for the Regulator to register the product and market approval to be provided. As long as all the relevant required information (as set out in the Medicines Act, its regulations and the Guidelines and Rules of SAHPRA) is contained in the application for registration of the product – which information would include where the clinical trial was conducted and the authorisation by the relevant international Regulatory Authority for the country in which the clinical trial was approved. There are separate processes available to applications for clinical trials which will be conducted within South Africa and for applications of registration of products where the clinical trials were conducted on other countries. Some requirements applicable to the standards of how the clinical trial was conducted will be reviewed by SAHPRA, as it will be documentation required in order for a full review to be completed prior to the application for registration of the product to be considered.
2. How are clinical trials funded?Clinical Trials are funded by a Sponsor. In terms of the Guidelines for Good Practice in the Conduct of Clinical Trials with Human Participants in South Africa which is published by the Department of Health, a Sponsor is “the person or organisation responsible for the initiation, management or financing of a clinical trial.” In the above context a Sponsor can be a Principle Investigator (PI) of the trial, a pharmaceutical company, a funding body or an individual or organisation designated by the funding body or principal investigator.
3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?Clinical Trial protocols should include information on the following:
- General Information
- Background information
- Trial Objectives and Purposes
- Trial Design
- Selection and withdrawal of subjects
- Treatment of subjects Assessment of Efficacy
- Assessment of safety
- Direct Access to Source Data/Documents
- Quality control and Quality Assurance
- Data Handling and Record keeping
- Financing and Insurance
- Publication Policy
4. What are the requirements for consent by participants in clinical trials?In order for consent to be obtained in accordance with the legislative and regulatory compliance requirements, it must adhere to the following: The Primary Investigator in a Clinical trial is responsible to ensure that adequate information is compiled in an information package, which must be in an acceptable format. The importance within the South African context lies in the fact that the potential trial participant must provide informed consent. The onus is much higher to ensure the potential trial participant provides not only consent, but consent with all the information at their disposal and with an understanding of what they are actually consenting to. This requires that the potential trial participant provides both verbally and in writing, consent to be a participant in the clinical trial, which include informed consent indicating their understanding of the following:
- That the trial involves research;
- The purpose of the trial;
- The trial treatment(s) and the probability for random assignment to each treatment (where appropriate);
- The trial procedures to be followed, including all invasive procedures;
- The participant’s responsibilities;
- The fact that participation in the trial is voluntary and refusal to participate or withdrawal from the trial will not prejudice the ongoing care of the person in any way;
- Those aspects of the trial that are experimental;
- The foreseeable risks of harm or inconveniences to the participant and, when applicable, to an embryo, foetus or nursing infant;
- The expected benefits. When there is no intended clinical benefit to the participant, the participant should be made aware of this (e.g. phase I Clinical Trial);
- The alternative procedure(s) or course(s) of treatment that may be available to the participant, and their important potential benefits and risks;
- The compensation and/or treatment available to the participant in the event of trial-related injury;
- The anticipated prorated payment, if any, to the participant for participating in the trial;
- The anticipated expenses, if any, to the participant for taking part in the trial;
- Allow access of sponsor, MCC National Health Research Ethics Council, relevant research ethics committee and/or other regulatory authority(ies) (pending that they have received permission to do so from the National Health Research Ethics Council) to participant records;
- Provide a contact name and number of the Primary Investigator and directly responsible investigator;
- The identity of a sponsor and any potential conflict of interests; and
- The requirement to preserve the confidentiality of the
- The expected duration of the subject’s participation;
- The Foreseeable circumstances and/or reasons under which the subject’s participation in the trial may be terminated;
- The approximate number of subjects involved in the trial.
5. May participants in clinical trials be compensated?This is an aspect within the South African Clinical Research context which requires and receives careful consideration. The general rule is that an incentive should not be so excessive so as to unfairly influence a participant’s inclusion in a trial – basically they should not feel, with what they are being offered to take part in the study, that it is “an offer they cannot refuse”. The sponsor of the trial must further ensure that information on incentives offered to participants involved in a specific trial, is included in the protocol. Where a trial is multi-centered (where a clinical trial is conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator) information on the incentives given to participants at all the different trial sites, irrespective if these are multinational, must also be provided. If there is a difference in the type of incentive offered across the different sites, this discrepancy must be explained.
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?They are allowed to be checked and treated by the physician who is in charge of the trial, namely the Principal Investigator. The Trial participant remains the responsibility of the qualified physician (or dentist, when appropriate), who may be the Principal Investigator or a sub-investigator for the trial – this person should be responsible for all trial-related medical (or dental) decisions. There is a responsibility placed on the Principal Investigator which include that he should ensure that adequate medical care is provided to a participant for any adverse events, including clinically significant laboratory values, related to the trial. There is an additional onus on the Principal Investigator to inform a participant in the event that they do require medical care for intercurrent illness(es) of which the Principal Investigator/Investigator becomes aware.
Also from this Legal Handbook
8. Regulatory, Pricing and Reimbursement: South Africa
1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?The South African Health Products Regulatory Authority (SAHPRA), previously known as the Medicine and Control Council (MCC).
2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?The legislation regulating the framework for the authorization, pricing and reimbursement of drugs, biologicals and medical devices include the Medicines and Related Substances Act (as amended), Act No 101 of 1965 (the Medicines Act) and its Regulations. There are also Industry Rules and Guidelines which supplement the Act and its Regulations. These Rules and Guidelines are published by SAHPRA. Price control is managed through different processes, one being a Pricing Committee which is appointed by the Minister of Health in terms of Section 22G of the Act. The Pricing Committee has the authority to make recommendations to the Minister to make regulations on the introductions of a transparent pricing system for all medicines and Scheduled Substances sold in the Republic. Such recommendations include an appropriate dispensing fee to be charged by a pharmacist or by a person licensed in terms of section 22C1 (a) and/or on an appropriate fee to be charged by wholesalers or distributors or any other person selling Schedule 0 medicines. The transparent pricing system referred to, includes a single exit price in terms of this Section and is the only price at which manufacturers shall sell medicines and Scheduled substances to any person other than the State. Medical Schemes also exist in South Africa whereby an undertaking of liability is present in return for a premium or contribution to make provision for obtaining any relevant health service. This liability includes the rendering of a relevant health service either by the medical scheme itself or by any supplier or group of suppliers in association with or in terms of an agreement with a medical scheme. The above-mentioned reimbursement of drugs, biological and medical devices is regulated by the Medical Schemes Act, No 131 of 1998.
3. What are the steps to obtaining authorization to develop, test, and market a product?The process to develop, test and market is regulated under the Medicines Act and by SAHPRA. The Conduct of clinical trials for humans and animals are set out in Regulation 30 of the General Regulations under the Medicines Act. The application document to conduct a Clinical Trial can be obtained from the SAHPRA website and provides detailed information on the required documentation and information prior to submitting an application. An applicant for registration of a medicine has to adhere to specific requirements which include but are not limited to the following:
- must be eligible to do business in South Africa, which include for example that they must be a person, body corporate/juristic person, company, residing and doing business in South Africa; or any other type of company/business;
- the application must be signed by the Responsible pharmacist authorized on behalf of the company/ juristic person to communicate with the Regulator; and
- the applicant should also submit a Site Master File in accordance with the
4. What are the approximate fees for each authorization?Fees for different applications differ. The fees are set out in Government Gazette No 39154 dated 1 September 2015. The fee for an application for a new Chemical Entity for example (other than vaccines) which have been processed by the abbreviated registration process is ZAR 49 000-00. For each application sought in the different categories, the specific details are contained in the Gazette.
5. For how long are marketing authorizations/registrations valid? How are marketing authorizations/registrations renewed?A Registration certificate is issued in terms of Section 15 of the Medicines Act and the process of application for such registration is contained in Regulation 16 under this Act. Once the Registration certificate is issued, a license must be obtained for the relevant activity to be conducted, e.g. licence for manufacturing, licence to distribute and/or a wholesaler’s licence. In terms of Section 22E of the Medicines Act, the Director-General has the authority to suspend or revoke the license should the applicable annual fee not be paid. A licence is valid for a period of 5 years from the date of issue. To renew a licence issued in terms of Section 22C, an application to the Regulatory Authority must be made as set out in regulation 24 of the General Regulations contained under the Medicines Act. The application for renewal must be made at least 180 days before the expiry of the existing licence.
6. How does the authorization process differ between brandname products and generic products? Are there differences for local manufacturers versus foreign-owned manufacturers?An applicant/proposed holder of the certificate of registration must be eligible to apply for the registration of the medicine in the first place. These eligibility criteria are contained in the General Information document of the South African Regulatory Body which is available on their website. The application for registration of a brand name and generic is done through the use of one application document. The document contains a section which require the particulars of the medicine to be registered, the differentiation between which category of medicine (generic or branded for example) is to be registered, is to be provided by the applicant in this section. Currently there are 5 different categories of medications for which an application for registration (and obtaining of market authorization) can be made:
- New chemical entity applications
- Multisource/generic applications and innovator product line extension applications that include clinical information in support of efficacy and safety of the formulation/dosage form, or indication/s or dosage regimen.
- Multisource/generic applications and innovator line extension applications that include comparative bio-availability/bioequivalence studies as proof of efficacy.
- Multisource/generic applications and innovator line extension applications
- that include comparative dissolution studies as proof of efficacy
- that include any other comparative studies as proof of efficacy
- others not mentioned above e.g. liquids/solutions.
- Biological medicines: Biopharmaceuticals and Biosimilars
7. How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug + biologic + device) regulatedCombination products is also Regulated by the Medicines Act and the Regulations under the Act, as well as Guidelines from SAHPRA regarding Registration of Medicines. Where the combination products are medications or medications together with biologics, the General Regulations under that Act apply. A combination of medications with a medical device, a biologic combined with a medical device or where a medication, biologic and medical device is combined, is regulated by the Regulations under the Medicines Act relating to medical devices and In Vitro Diagnostic medical devices (IVDs).
8. How is compliance with regulation monitored and evaluated? Is the regulatory regime comparable with the U.S. Food and Drug Administration or the European Medicines Agency expectations and requirements?Regulation and compliance is monitored by means of implementation of Section 26 of the Medicines Act. This Section provides that the Chief Executive Officer can authorize persons as inspectors in order to ensure the proper enforcement of this Act. Section 28 set out the specific powers of an Inspector with regards to how they are able to enforce the requirements of this Act.
9. What is the potential range of penalties for noncompliance?In terms of Section 29 of the Medicines Act, any person who is found be non-compliant with the requirements of the Act shall be guilty of an offence. If a person is found to be non-compliant and guilty of an offence as set out in Section 29 of this Act and is convicted of the offence, shall be liable to a fine, or to imprisonment for a period not exceeding 10 years.
10. Is there a national healthcare system? If so, how is it administered and funded?Currently in South Africa there is no national healthcare system. The South African Government is in the process of developing National Health Insurance (NHI), which they plan to fully implement by 2025. At the moment there are Government public hospitals which patients without medical insurance can access. Persons able to afford private medical insurance, can access private hospitals depending on the specific medical aid plan they pay for.
11. How does the government (or public) healthcare system function with private sector healthcare?Currently the government (public) healthcare system functions completely separate from the private sector healthcare.
12. Are prices of drugs and devices regulated and, if so, how?The prices of drugs and devices are regulated in terms of Section 22G of the Act, which provide for the appointment of a Pricing Committee. This Committee consist of 18 members from different industries and professional fields and include a person nominated by the Minister of Finance, a person nominated by the Minister of Trade and Industry, a person representing the Department of Health, and other persons which include a person with a pharmacology background, a legally qualified person, a person with medical research background. Importantly at least two persons with economics backgrounds, one of whom must be a health economist is also on this list and finally one person who represents independent patient or consumer groups. There are also Competition Laws in place to prevent anti-competitive behaviours which would include price fixing or coercive behaviour by pharmaceutical companies with regards to pricing.
13. How are drugs and devices used by patients paid for? What roles do public and private payers play?In the Government (public) healthcare sector, the government substitutes the healthcare and in Private healthcare sector, the patient either pays for the treatment themselves or if they have a medical aid, the medical aid (like health insurance) covers the treatment depending on the level of the plan and the primary medical benefits which are included. Some patients have to pay a part of the cost of their treatment despite having a medical aid as a result of their specific plan not covering all or certain aspects of their treatment.
14. Who dispenses drugs and devices to patients and how are those dispensers compensated?The dispensing of medication is regulated under the Medicines Act and specifically requires that persons registered as pharmacists or medical practitioners, registered with the relevant regulatory authority for their profession, dispense the medication in accordance with their scope of practice and in accordance with the provisions of this Act, its Regulations and the requirements as set out by SAHPRA in this regard. It is also important to note that a Licence to dispense or Compound and Dispense Medicines is required in terms of Regulation 22 of the General Regulations under the Medicines Act. The Pharmacy Act No 53 of 1974, as amended, also regulates the practice of Pharmacists in the dispensing of medication, medical devices and/or IVDs. The Pharmacy Act defines “Dispensing” as “the interpretation and evaluation of a prescription, the selection, manipulation or compounding of the medicine, the labelling and supply of the medicine in an appropriate container according to the Medicines Act and the provision of information and instructions by a pharmacist to ensure the safe and effective use of medicine by the patient and “dispense” has a corresponding meaning”. The professional acts specifically pertaining to the profession of a pharmacist is contained in Section 3 of the Pharmacy Act and includes:
- Provision of pharmaceutical care by taking responsibility for the patient’s medicine related needs and being accountable for meeting these needs, which shall include but not be limited to the following functions:
- evaluation of a patient’s medicine related needs by determining the indication, safety and effectiveness of the therapy;
- dispensing of any medicine or scheduled substances on the prescription of a person authorised to prescribe medicine;
- furnishing of information and advice to any person with regard to the use of medicine;
- determining patient compliance with the therapy and follow up to ensure that the patient’s medicine related needs are being met; and
- the provision of pharmacist-initiated therapy.
- The compounding, manipulation, preparation or packaging of any medicine or scheduled substance or the supervision thereof;
- The manufacturing of any medicine or scheduled substance or the super vision thereof;
- The purchasing, acquiring, importing, keeping, possessing, using, releasing, storage, packaging, repackaging, supplying or selling of any medicine or scheduled substance or the supervision thereof; and
- The application for the registration of a medicine in accordance with the Medicines