Marketing, Manufacturing, Packaging & Labeling, Advertising
An insight into marketing, manufacturing, packaging & labeling, advertising in United Kingdom. Prepared in association with Clyde & Co, a leading law firm in United Kingdom, this is an extract from The Pharma Legal Handbook: United Kingdom, available to purchase here for USD 99.
1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?
The authorisation process is discussed in the answer to Questions 2 and 3 in Regulatory, Pricing and Reimbursement Overview.
2. What is the authorization process for the marketing of generic versions of these products?
The authorisation process for generic drugs is discussed in the answer to Question 6 in Regulatory, Pricing and Reimbursement Overview.
3. What are the typical fees for marketing approval?
The typical fees are discussed in the answer to Question 4 in Regulatory, Pricing and Reimbursement Overview.
4. What is the period of authorization and the renewal process?
The authorisation periods and renewal processes are discussed in the answer to Question 5 in Regulatory, Pricing and Reimbursement Overview.
5. What are the requirements, if any, for post-approval pharmacovigilance?
National UK and EU legislation on pharmacovigilance was largely consolidated and implemented in Part 11 of the HMR. This included the implementation of Directive 2010/84/EU, which was intended to introduce a strengthened, clarified and more proportionate pharmacovigilance regime. In particular, since June 2016 it has been mandatory for MAHs to submit periodic safety update reports (PSURs) for both centrally and nationally authorised human medicines to a central repository run by the EMA. A PSUR should summarise all data relevant to the benefits and risks of the medicine, including all studies (including on new indications), investigations on product safety, patient sup- port programs and so on.
The MHRA is responsible for overseeing compliance by MAHs with their obligations under the regime and has produced guidance in the form of the “Good Pharmacovigilance Practice” (GPvP), which sets minimum standards for compliance and which is backed up by GPvP inspections. The GPvP is extensive but the essential obligations on MAHs include operating a pharmacovigilance system that:
- has an appropriately qualified person responsible for pharmacovigilance located within the EU;
- includes maintaining a pharmacovigilance system master file (PSMF) and making it available to the MHRA for inspection within a seven day period from the date of an inspection request; and
- includes operating, monitoring, updating and regularly auditing the system and risk management system for the medicine.
As with its enforcement powers generally (discussed in the answers to Questions 8 and 9 in Regulatory, Pricing and Reimbursement Overview), the MHRA takes a risk-based approach to the scheduling and frequency of inspections and will generally give advance notice of an inspection to the MAH. The MHRA no longer requires the filing of routine GPvP compliance reports by MAHs to assist it in deciding when to conduct inspections as it has access to all PSURs. As well as routine inspections, the MHRA will conduct “triggered” inspections where it has received information of a possible GPvP breach from, for example, a whistleblower or regulatory authority in another EU state.
The MHRA also conducts inspections as the supervisory authority for authorisations granted under the CP where the MAH has located its pharmacovigilance system master file in the UK. The EMA coordinates such inspections, which are generally on a 4-year cycle. The inspections are typically conducted by the MHRA following the same approach as for its routine national inspections.
Following an inspection, a report will be issued with any proposed corrective and preventative actions required from the MAH. In the case of serious or serious and persistent breaches of GPvP, the MHRA may issue an infringement notice.
6. Are foreign marketing authorizations recognized?
Marketing authorisations issued outside the EEA are not recognised by the EMA or MHRA. To market a medicine in the UK, an authorisation covering the UK must be obtained through one of the procedures described in the answer to Question 3 in Regulatory, Pricing and Reimbursement Overview.
As said in the answer to Question 6 in Regulatory, Pricing and Reimbursement Overview, only applicants that are established in the EU can obtain a marketing authorisation.
7. Are parallel imports of medicines or devices allowed?
The parallel importation into the UK of a medicine authorised in another EU member state is permitted provided that it has no therapeutic difference to the associated UK product, it is manufactured according to good manufacturing practice, the packaging and patient information leaflet comply with EU guidance and the importer holds a wholesaler’s licence and the correct parallel import licence. If the product requires assembling or repackaging, then a manufacturer’s licence will be required as well.
Parallel import licences are granted by the MHRA, except in the case of drugs controlled under the Misuse of Drugs Act 1971, in which case an import licence from the Home Office is required. A parallel import licence from the MHRA is granted for a period of 5 years and can be renewed. The MHRA’s fees vary from £1,792 for a simple application to £18,180 for a complex one.
The patent and trade mark implications of parallel importation are discussed in Patents & Trademarks.
A medical device that has obtained its CE marking, and is already on the market in one EU country, can technically be marketed anywhere else in the EU including the UK (provided that the product meets the requirements of the relevant EU legislation). However, if the importer rebrands the device so that it is marketed under its own name or makes any changes to the product such that it is no longer covered by the CE mark, which includes changing the manufacturer’s lot or brand number, then the device will need to be re-submitted for CE marking by the importer before it can be marketed.
Certain changes will not result in the importer becoming manufacturer of the device, and so having to resubmit it for CE marking, such as changing the language of the packaging and instructions or making other changes necessary for marketing in the UK as long as the original condition of the device is not affected.
An interim procedure applies for the parallel importation of self-test IVDs due to the requirement that they should be labelled in the language of the EU member state of the user. A person intending to import such devices should contact the MHRA.
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 general law on gifts and incentives is set out in the Bribery Act 2010 (2010 Act). Healthcare organisations and/or individual medical practitioners may fall foul of the 2010 Act if any activity falls into one of the following categories of offences:
- the general offences of promising, offering or giving or requesting, agree- ing to receive or accepting an advantage (financial or otherwise), in circumstances involving the improper performance of a relevant function or activity (i.e. the offences of making or accepting a bribe for a function or activity that should be performed in good faith, impartially or as a result of a position of trust);
- the offence of promising, offering or giving an advantage (financial or otherwise) to a foreign public official (FPO) intending to (1) influence the FPO in his/her capacity as such; and (2) thereby obtain/retain business or a business advantage; and/or
- the strict liability offence committed by corporate entities that fail to prevent bribery by those acting on their behalf (their associated persons), where the bribery was intended to obtain or retain a business advantage for the corporate entity.
The guidance surrounding the Act is clear that the aim is not to stop corporate hospitality (such as gifts, entertainment and other incentives) per se, but to prevent bribery, including facilitation or “grease” payments, under the guise of corporate hospitality.
As regards the corporate offence, it is a defence for the corporate entity if it can demonstrate that it had adequate procedures in place designed to prevent bribery taking place. The procedures should be proportionate to the risks taking account of factors such as top-level commitment to anti-corruption, due diligence on potential risks, training in the company’s policies and procedures and periodic review.
More specifically for the pharmaceutical industry, the HMR contains provisions preventing the giving of free samples of medicines except on certain conditions (including that it is to a person qualified to prescribe, on an exceptional basis and in response to a request) and preventing the use of inducements or hospitality in the promotion of medicines except in limited circumstances. Gifts and benefits may only be given, offered or promised, if they are inexpensive and relevant to the practice of medicine or pharmacy. Hospitality can only be provided if strictly limited to the purpose of the meeting (i.e. the promotion of a medicine) and the recipient is a healthcare professional.
In addition, the ABPI has a Code of Practice for the Pharmaceutical Industry (the “ABPI Code”), which all of its members have to agree to abide by (a large number of non-members have also agreed to follow it). The current edition of the ABPI Code was issued in 2019. Although primarily aimed at the self-regulation of the promotion and advertising of medicines, the ABPI Code also includes provisions against inducements to health professionals to prescribe, recommend, supply or buy medicines unless they are, for example, inexpensive items that are part of a formal patient support programme or inexpensive notebooks, pens and pencils for use at promotional meetings and conferences. The ABPI Code also includes provisions on the disclosure of transfers of value to health professionals and healthcare organisations. Typical transfers of value include donations, grants and benefits in kind, contracts awarded, sponsorship and fees and expenses paid.
A similar code of practice is issued by the Association of British Healthcare Industries (ABHI) in respect of the medical technology industry called the “Code of Ethical Business Practice” (the “ABHI Code”). Like the ABPI Code, the ABHI Code gives a self-regulatory regime that has to be signed up to by members (and non-members can sign up as well). The ABHI Code says that members may provide inexpensive educational items and/or gifts that relate to the healthcare professional’s practice, that benefit patients or that serve a genuine educational function, and are not in the form of cash or cash equivalents. More expensive items can only be provided if, amongst other things, they are not for the healthcare professional’s personal use and are related to the therapeutic areas of the member company.
9. How is the manufacturing of medicines and devices regulated and by which agencies?
The regulation of medicines and medical devices, and responsible agencies, is discussed in the answers to Questions 1 and 2 in Regulatory, Pricing and Reimbursement Overview.
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 Good Manufacturing Practice (GMP) requirements in the UK are similar to the current practice in the US. The UK requirements are largely derived from EU legislation, including Regulation 1252/2014 and Commission Directive 2003/94/EC applying to active substances and medicines for human use. Compatibility with the FDA’s requirements on GMP is discussed further in the answer to Question 12 below.
11. What is the inspection regime for manufacturing facilities?
The Inspectorate Group of the Inspection and Standards Division of the MHRA (MHRA Inspectorate) conducts inspections to ensure that medicines are of consistent high quality, are appropriate to their intended use and meet the requirements of the marketing authorisation or product specification. To that end the MHRA Inspectorate has extensive regulatory powers as discussed in the answer to Question 8 in Chapter 1. As described there, and above regarding pharmacovigilance, the MHRA takes a risk-based approach to routine inspections as well as conducting triggered inspections in response to information from whistleblowers or other regulatory authorities.
In addition, the MHRA Inspectorate conducts inspections when a manufacturer applies to it for a national marketing authorisation. Where the manufacturing facilities are in the UK, such product related inspections can also be requested by the EMA in respect of marketing authorisations under the CP or using the MRP or DCP.
Before an inspection is made, unless a trigger inspection at short notice, the manufacturer has to submit a compliance report to the MHRA. During the inspection the MHRA may ask for additional documentation and may take samples. At the end the inspector will discuss deficiencies with the manufacturer and a timetable for corrective action (which will be confirmed by follow-up letter).
If the inspection reveals a critical deficiency (i.e. one that has produced or risks producing a product that is harmful to humans or one that results in a significant risk to patients) or that there are unresolved deficiencies from a previous inspection, then the manufacturer can be refused a marketing authorisation or have its existing authorisation suspended or face increased inspections.
Both the EMA and MHRA have published guidance on GMP and inspections.
As regards medical devices, manufacturing is assessed as part of the CE certification process (by reference to the standards in the Medical Devices Directives as well as international standards such as ISO 13485:2016 (on quality management systems for medical devices) and ISO 9001:2015 (on quality management systems). Further, in addition to routine surveillance and audits on recertification, following European Commission Recommendation 2013/473/EU and now formalised in the EU MDR, notified bodies are required to conduct unannounced audit visits at least once every 3 years to all holders of CE marks for devices that required a conformity assessment by a notified body to obtain certification. Unlike routine surveillance, which is focused on quality systems, unannounced audits are focused on day-to-day compliance in the manufacture of a specific product (or products) covering matters such as conformity with technical documents and legal requirements, traceability of components, assembly, packaging and quality control and can also include testing of samples.
The manufacturer will receive an audit report setting out any non-compliance found and have 60 days to respond, explaining the cause of the non-compliance and planned corrective actions. An audit could result in suspension of certification. The costs of the audit are borne by the manufacturer.
12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?
The FDA can carry out inspections in the EU (and vice versa). However, the EMA and FDA have cooperated in various initiatives on GMP inspections since 1998 aimed at reducing duplication and allowing better use of resources by focusing on inspections of facilities that present potentially greater risks. Thus, in June 2017, the European Commission confirmed that the FDA is competent in carrying out GMP inspections at an equivalent level to the EU. Further, in November 2017, a Mutual Recognition Agreement (MRA) on GMP inspections between the EU and FDA came into effect, with a transitional phase until July 2019 during which the FDA has been conducting capability assessments of the national regulatory authorities in each EU member state on a rolling basis. Most national authorities are now recognised as competent by the FDA (confirmation of the UK’s compatibility was given in November 2017).
The MRA is supported by confidentiality agreements allowing for the exchange of inspections reports and other information (e.g. on post-authorisation surveillance).
At present the scope of the MRA is limited to medicinal products for human use, though it will be extended to include veterinary medicines, vaccines and plasma-derived medicinal products as well.
The EU has also entered MRAs on GMP with Australia, Canada, Israel, Japan, New Zealand and Switzerland though generally they only cover exchange of GMP certificates and 2-way alert systems.
13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?
The European Commission has published guidance on Good Distribution Practice (GDP) for medicinal products for human use (Commission Guidelines 2013/C 343/01) and on principles of GDP for active substances for medicinal products for human use (Guidelines 2015/C 95/01). Essentially the guidance is to ensure that:
- medicines in the supply chain are properly authorised;
- medicines are stored in appropriate conditions during warehousing and transport;
- contamination by or of other products is avoided;
- there is adequate turnover of stored medicines; and
- products reach the right addressee within an appropriate timeframe. Specific requirements include, for example, that:
- medicinal products should be stored separately from other products likely to alter them and should be protected from the harmful effects of light, temperature, moisture and other external factors;
- warehouse storage facilities should have appropriate security;
- stock should be rotated according to the “first expiry, first out“ principle and medicinal products nearing their expiry date should be withdrawn immediately from saleable stock;
- inventories should be performed regularly and any irregularities investigated and documented; and
- measures should be in place to prevent spillage, breakage, contamination and mix-up during handling.
While MAHs do not require separate authorisations to distribute their products, wholesalers must be licensed by the MHRA, which requires showing compliance with EU GDP (by following the above guidelines). Similarly, manufacturers, importers and distributors of active substances for use in the manufacture of human medicines that are based in the UK must be registered with the MHRA and must comply with GMP and/or GDP.
Packaging and labelling requirements are described in the answer to the next Question.
14. What information must be included in medicine and device labeling?
The source legislation regarding labelling is Title V of Council Directive 2001/83/EC (as amended), and Part 13 and Schedule 24 of the HMR. The MHRA oversees compliance with labelling requirements of all medicines sold in the UK and has issued best practice guidance, based upon its move towards increased self-regulation by the pharmaceutical industry.
A first point is that, with limited exceptions, all information necessary to meet the requirements of the HMR must be in English.
Part 1 Schedule 24 sets out the key requirements for the outer and immediate packaging for medicines (POMs and OTC), though under Article 54 of Directive 2001/83/EC certain information is deemed critical: the name of the medicine (which must also be in Braille); the expression of its strength; the route of administration; its posology (a legal requirement for OTC medicines); and, any warnings required by the terms of the medicine’s marketing authorisation. This information should be placed together on the package, within the same field of view, and more prominently than other information. In addition, the full name of the medicine should appear on at least 3 non-opposing faces of the package (with the names of the active ingredient(s) immediately following).
Further key requirements are that: those excipients known to have a pharmacological effect in their own right have to be identified; and, the registered indications of OTC medicines (pharmacy-only and GSL) must be given as part of the critical information. And, under Commission Delegated Regulation (EU) 2016/161, all medicines must have a unique identifier (as well as tamper evident features).
Other non-critical information that should be given covers matters such as: whether the product is for babies, children or adults; for injectable, topical and eye products, all excipients; the MAH and authorisation number; the batch number; expiry date; and, any special storage requirements. Space should also be left on the packaging of prescription medicines for a dispensing label to be applied by the pharmacist. Particular requirements also apply to blister packs including that the name and strength of the product should, where practicable, be printed over each blister pocket or be orientated centrally across the pack. Controlled drugs should be identified by the letters “CD” in an inverted triangle.
If the label does not contain all the necessary information, then the packaging for a medicine must contain a patient information leaflet.
(ii) Medical Devices
Regulations around medical device labelling have not traditionally been as comprehensive as medicines. However, the definition of “label“ alone has expanded over the years to include a multi-lingual booklet and Instructions For Use (IFUs).
The current information requirements are set out in the UK MDR by reference to the Annexes of the Medical Devices Directives discussed in the answer to Question 2 in Regulatory, Pricing and Reimbursement Overview. As with medicines, for devices sold in the UK, the label information has to be in English. The required information is then:
- the CE mark in visible, legible and indelible form and the notified body or conformity assessment body identification number;
- name and address of the manufacturer (if imported then the EU representative);
- details to identify the device and the contents of the packaging;
- batch code/serial number;
- where appropriate:
- the word “sterile”;
- the use-by date (as year and month);
- that the device is for single use;
- that the device is “custom made”;
- that the device is exclusively for clinical investigations; o the method of sterilization;
- any special storage and/or handling conditions and/or operating instructions;
- intended purpose (if not obvious to the end-user); and
- if no use-by date, the year of manufacture (which can be part of the batch or serial number).
The IFU must also contain the above items (except for batch number and use-by date) and further information such as: any undesirable side-effects; information on installation (including calibration) and connections with other devices; risks; sterilisation methods; and, contraindications and precautions. IFUs for implantable devices must have additional information for both the doctor and the patient regarding implantation, connections, interference risks, battery life, use and date of issue. Similarly IFUs for IVDs should contain details such as reagents used, storage conditions for the device once opened and reagents, the type of specimen to be used, the measurement procedure and mathematical approach for calculating the analytical result, and instructions on re-use and for self-testing.
However, while maintaining many of the above information requirements, the incoming EU MDR and EU IVDR will add certain significant aspects to them, requiring advance preparations by medical device manufacturers to avoid the risk that their products cease to be marketable in the EU. The key additional label requirements include:
- inclusion of a standardised symbol to indicate that the package contains a medical device;
- use of a Unique Device Identification (UDI) (as part of the global UDI initiative);
- inclusion of the symbol, name and address of any EU representative for a device; and
- more detailed information on warnings/precautions (information which under current rules can be in the IFU will have to be included in the label, though the EU MDR says it can be kept to a minimum).
It should also be mentioned that the use of symbols to communicate information, such as where a device is re-usable and any use-by date, is increasing and is covered by ISO 15223-1:2012.
15. What additional information may be included in labeling and packaging?
See the answer to Question 14 above. In addition, for medicines, non-statutory information useful for the patient can be included in the label and patient information leaflet but it should be compatible with the SmPC and not be promotional. It could, for example, be additional information about the way in which the medicine works and the disease it is intended to treat, which is of benefit to patients on long-term medication. QR codes (i.e. barcodes) can also be on packaging provided they are subordinate in prominence and placement to the statutory information.
Further, a member state may require that certain additional information on price, reimbursement conditions, legal supply and authenticity and identification should be included on the package. Due to the principle of free movement of goods, this information should be contained in a so-called “blue box” in the official language of the member state concerned so that it is distinct from the other information on the packaging. The blue box should be located in the same position for the particular medicine’s packaging in all member states. The only information that the UK requires to go in the blue box is the legal status of the medicine, i.e. “POM” or “P” (for pharmacy medicines).
16. What items may not be included in labeling and packaging?
The legislation discussed in the answer to Question 14 is drafted in terms of what should (or can) be included in labelling or on packaging, rather than what should not be. However, the MHRA’s guidance on labelling of medicines identifies the following as statements or wording that should not be used:
- promotional information;
- negative statements – only positive statements should be used to avoid ambiguity, for example if a product is for intravenous use only, it should say so whereas other products should not say “Not for intravenous use”;
- medical terminology (unless there is evidence from user testing that it is understood); and
- abbreviations of the medicine’s name as registered in the SmPC.
The guidance also advises on the use of statements about conditions, indications, speed of action, formulation and population groups for OTC medicines aimed at avoiding them being misleading and being compatible with any SmPC. For example, a product that relieves symptoms should not be said to cure the underlying condition. Nor should a statement such as “suitable for people with diabetes” be used if, although a product is sucrose free, it contains other sugars.
Medical devices are subject to similar general rules against misleading medical claims and also a disclaimer such as “this is not a medical device” should not be applied to a device if medical claims are made or implied elsewhere in its labelling, packaging or IFU etc.
17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?
The advertising of medicines in the UK is regulated by a combination of legislation and industry codes of practice. The relevant legislation is Titles VIII and VIIIa of Directive 2001/83/EC implemented by Part 14 of the HMR. Guidance on the HMR is provided by the MHRA’s “Blue Guide”, which construes advertising broadly as any thing or activity, using any form of media, intended to encourage the prescribing or use of medicines, though it does not include e.g. factual statements, price lists, reference materials or the packaging and patient information leaflet.
The codes of practice, aimed at self-regulation by the industry, are:
- the ABPI Code – as mentioned in the answer to Question 8 above, all member companies of the ABPI are obliged to abide by the ABPI Code, and non-member companies have also agreed to comply with it. The ABPI Code reflects, and in some respects goes beyond the requirements of, the relevant law on the promotion of POMs to healthcare professionals and certain administrative staff. It also covers information made available to the public about POMs. The ABPI Code is administered by the Prescription Medicines Code of Practice Authority (PMCPA).
• the advertising codes issued by the Proprietary Association of Great Britain (PAGB), which represents manufacturers of branded OTC medicines and self-care medical devices. PAGB publishes 2 advertising codes – one on advertising of OTC medicines (and registered traditional herbal medicines) to consumers and the other on advertising to prescribers.
More generally, the promotion of medicines also has to comply with the standards set for all advertising in the UK, for which the Advertising Standards Authority (ASA) is the UK’s independent regulator and issues codes of practice (for broadcast and non-broadcast adverts) (the “ASA Codes”). The MHRA works with the ASA, and its committee that drafts the codes. Further, there is legislation concerning broadcast advertising as well as provisions governing advertising generally in consumer legislation such as the Business Protection from Misleading Marketing Regulations 2008/1276 and Consumer Protection from Unfair Trading Regulations 2008/1276. As their names imply, these Regulations prohibit misleading advertising, including misleading comparative advertising.
Given these numerous sources, only the general rules identified in the Blue Guide and the key provisions regarding the promotion of medicines to healthcare professionals will be discussed further. The key provisions concerning the general public are discussed in the answer to Question 20 below.
The Blue Guide’s general rules are that:
- it is not permitted to advertise medicines that are not licensed, save in limited circumstances such as providing factual information regarding new treatments expected to give rise to significant costs advantages over standard treatments.
- additional restrictions apply to the advertising of traditional herbal or homeopathic registration (discussed in the answer to Question 2 of Traditional Medicines and OTC Products).
- all advertisements must:
- comply with the particulars listed in the SmPC (the advert can contain additional evidence if that evidence can be substantiated and is not inconsistent with the SmPC);
- encourage the rational use of medicines, in particular by not exaggerating the properties of a product; and
- not be misleading, particularly as to the potential benefits or risks of a medicine.
Advertisements to healthcare professionals must then include the following information:
- the authorisation or registration number and holder;
- the legal classification of the product as a POM, pharmacy medicine or GSL;
- the name of the product;
- a list of the active ingredients(s), using their common names and placed next to the most prominent display of the product name;
- the medicine’s indication(s) consistent with its marketing authorisation or registration details;
- a summary of the information in the SmPC on adverse reactions, contraindications, dosage and method of administration (where not obvious), which must be printed clearly and legibly and in such position that their relationship to the claims and indications for the product can be readily appreciated; and
- the cost.
These requirements are modified for short-form advertisements (which must be no larger than 420 square centimetres in size).
In any form of advertisement, it is not acceptable to state or imply that a medicine is safe, though it can be said that it is safer than an alternative or well tolerated, in both cases if supported by evidence.
(ii) Medical Devices
There is a general assumption that there is a lower risk of misuse with medical devices compared to medicines. As a result, the legislative control on advertising of medical device is not as comprehensive as that for medicines. Nor do the industry codes or the Blue Guide discussed above apply. Therefore, advertising of medical devices is primarily governed by the general consumer legislation mentioned above and the ABHI and ASA Codes.
The ABHI Code only applies to advertisements directed at healthcare professionals. Essentially the ABHI Code requires that:
- advertisements must be accurate, balanced, fair, objective, unambiguous and supported by up to date substantiation for all information, claims and comparisons;
- claims and comparisons must accurately balance all relevant evidence, which should be scientifically robust;
- advertisements should encourage the appropriate use of a device; and
- comparisons with other medical devices should not be misleading, should be supported by clear evidence, should compare devices for the same intended purposes and should not create confusion with the competitor’s device or trade marks or otherwise take advantage of or denigrate the competitor’s mark, product or services;
- advertisements should not promote off-label use.
The ASA’s non-broadcasting code includes similar provisions on the need for robust evidence to support efficacy claims and advises that advertisements should not state or imply that a medical device can be used to diagnose or treat medical conditions unless under the supervision of a suitably qualified health professional. The ASA’s broadcasting code allows testimonials and endorsements of devices by suitably qualified healthcare professionals if genuine, supported by documentary evidence and any direct financial interest is made clear.
The packaging and labelling requirements discussed in the answers to Questions 13 to 16 above, should also be borne in mind.
18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?
As regards places from which medicines can be sold, see the answer to Question 14 of Regulatory, Pricing and Reimbursement Overview. However, medicines can also be sold at a distance or over the Internet, and delivered to the patient by post, subject to the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013. Guidance for such pharmacies is provided by the General Pharmaceutical Council (GPhC). In essence, the same requirement that POMs and pharmacy medicines can only be sold or supplied from a registered pharmacy under the supervision of a pharmacist still applies to pharmacies operating at a distance (e.g. by post) or over the Internet. The 2013 Regulations also provide that none of the essential services of a pharmacy should be provided face-to-face to a patient from a distance-selling pharmacy, that it must be capable of providing those essential services during all of its core opening hours and that it cannot restrict those services to particular locations in England or particular categories of patients. Nor can the pharmacy be in the same building as a doctor’s practice.
The Guidance further advises that the premises used must meet the standards for a registered pharmacy, patients should consent to the form of service being provided and it must not restrict the patent’s choice of pharmacy or unduly influence or mislead patients (e.g. about the identity and location of the pharmacy).
As regards web-based pharmacies, they must be registered with the MHRA, must display the “distance selling” logo on each webpage offering medicines and must provide MHRA contact details and link to its website. Further, the GPhC’s guidance advises that the website should display certain other information prominently such as its GPhC registration number, the name of the superintendent pharmacist, details of the registered pharmacy and says that the website may also display the voluntary GPhC logo. General legislation applicable to e-commerce will also need to be complied with.
Medical devices (that are correctly CE marked and have details of the appropriate notified body number) can either be supplied to patients on prescription or OTC. Where on prescription the above requirements apply to distance-selling. Otherwise general e-commerce legislation applies, though the EU MDR and EU IVDR cover distance-selling over the internet saying that their provisions generally have to be complied with and that the person or entity running the website has to make the EU declaration(s) of conformity for the device(s) being sold available upon request.
19. What are the restrictions and requirements for electronic marketing and advertising via email, by internet, social media, and other channels?
The same restrictions and requirements apply as are discussed in the answers to the above Questions.
The Blue Guide gives the MHRA’s opinion that Internet advertising for POMs is only acceptable on websites directed at healthcare professionals. Such websites (or the relevant sections of them) should ideally be access restricted. If no restriction is applied, and the website includes information and advertising aimed at both healthcare professionals and the general public, then these aspects should be clearly separated and clearly marked for the relevant target audience. To show that material on an open access website is “wholly or mainly directed” at healthcare professionals, the public areas should give adequate non-promotional information such that the public do not need to go to the sections for healthcare professionals (unless they choose to seek further detailed information, which should not be encouraged).
20. May medicines and devices be advertised or sold directly to consumers?
The background to and general rules on the advertising of medicines are discussed in the answer to Question 17. Specific rules concerning advertising aimed at the general public in the HMR are that:
- medicines cannot be sold or supplied for promotional purposes to a person who is not qualified to prescribe medicines.
- advertisements cannot be directed to the public that:
- are likely to lead to the use of a medicine to induce an abortion;
- are likely to lead to the use of a POM (i.e. advertising to the public should relate to OTC medicines only);
- relate to a medicine containing a narcotic or psychotropic substance; o state or imply that a consultation or operation is unnecessary, offer diagnoses or treatment by post or electronic communication or that may lead to an erroneous self-diagnosis;
- suggest that the effects of taking a medicine are guaranteed, better than another medicine or free of adverse reactions;
- are misleading or likely to cause alarm as to the effects of a disease or of a medicine;
- suggest it is not a medicinal product or is safe or efficacious due to the fact that it is natural;
- refer to a recommendation by a scientist, healthcare professional or celebrity; or
- contain materials primarily directed to children.
- it must be clear that it is an advertisement and the product a medicine and the advertisement must include the product name, the common name of the active ingredient (if there is only one), information on correct use and a clear invitation to read the instructions on the package or in the patient information leaflet.
The Blue Guide expands on the above requirements, for example stating that comparative claims for one medicine against another are prohibited (though comparisons to e.g. “standard tablets” are permissible). Claims that a product is e.g. “fast acting” or “provides 24 hour relief ” must be substantiated with clinical data (and brought to the target audience’s attention). Also, advertisements should not state that a product has MHRA or DHSC approval, or suggest that it is special or better than other medicines because it has approval.
In addition, the Cancer Act 1939 prohibits advertisements to the public that offer to treat cancer or prescribe a remedy for its treatment.
Devices can be sold directly to consumers but the device must be CE marked and can only be promoted for its intended use as set out in its labelling, instruction for use and technical file. Advertising to consumers is subject to the ASA Codes and the general consumer legislation discussed in the answer to Question 17.
21. How is compliance monitored?
Advertising compliance is monitored via the MHRA and industry self-regulation as discussed above in the answers to Questions 17 and 19.
The MHRA has the following powers enabling it to monitor and control advertising:
- checking advertising for compliance with the law prior to publication (vetting);
- monitoring of published advertising material for medicines;
- complaints handling about advertising; and
- enforcement including through criminal or civil proceedings (most breaches of the HMR’s provisions on advertising constitute a criminal offence).
The ABPI Code, and the complaints procedures under it, is administered by the PMCPA. While the PMCPA cannot approve advertising, it can offer guidance and training on what is acceptable. The ABHI Code complaints procedure is administered by the ABHI’s secretariat.
The ASA Codes are written by the Committees of Advertising Practice (CAP) and ASA and CAP together give training and guidance to industry. They also monitor advertisements and ASA runs a complaints procedure.
22. What are the potential penalties for noncompliance?
The HMR enables the MHRA to enforce penalties for non-compliance for various offences such as misleading advertising or failing to display the EU distance selling logo on websites selling medicines online. These powers, the MHRA’s approach to enforcement and the potential penalties are discussed in the answer to Question 9 in Regulatory, Pricing and Reimbursement Overview. The civil sanctions include the ability to require pre-vetting of advertisements and to require publication of a corrective statement targeted to the audience that saw the original advertisement and clearly stating that it is issued at the request of the MHRA.
Where a company is found by the PMCPA to be in breach of the ABPI Code, it must undertake to cease the practice complained of and give details of the action being taken to implement the ruling and to avoid such breaches in the future. Sanctions for more serious breaches include the issue of corrective statements, public reprimands and suspension or expulsion from the ABPI. A similar set of sanctions applies for breach of the ABHI Code.
The approach of the ASA to breach of its codes is to work with the defaulting companies to help them comply in the future. For persistent offenders, it can require the amendment or withdrawal of an advertisement (including online ones), issue alerts to members (including the media) advising them to withhold advertising space, require pre-vetting or refer the offender to bodies such as Trading Standards (which enforces consumer protection legislation) or Ofcom (the UK body which regulates broadcasting).