Regulatory, Pricing, and Reimbursement
An insight into regulatory, pricing, and reimbursement of drugs in Egypt. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for USD 99.
1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?
The pharmaceutical regulatory body in Egypt is the Egyptian Drug Authority (EDA) operating and working under supervision of the Ministry of Health (MOH) in Egypt.
The EDA comprises three independent organizations consisting of the following:
- Central Administration for Pharmaceutical Affairs (CAPA): which is mainly responsible for the registration and pricing of medicines, and inspection of pharmacies and manufacturing facilities.
The CAPA hosts four departments for registration: Licensing and Pharmacists services, Inspection and Control, and Importation and Exportation department.
- The CAPA includes a department (Egyptian Pharmacovigilance Center “EPVC”) that monitors the use of the drugs and medical devices after their registration.
- The National Organization for Drug Control and Research (NODCR): which is responsible for quality control of pharmaceutical products, medicines, medical plants, cosmetics, raw materials, insecticides, and products from natural origin. The organization entails many laboratories for testing all the pharmaceutical products under registrations, which will be marketed in Egypt.
- National Organization for Research & Control of Biologicals (NORCB): which is responsible for the marketing authorizations and licensing activities.
2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?
The authorization process is regulated by Decree 425 of the year 2015.
Pricing of drugs is regulated through a pricing committee. Any price increases of medicines and drug products are determined according to issued Ministerial Decrees.
The drug manufacturers recommend the prices of the new medicines, the pricing committee reviews the recommended prices, and the pricing committee then determines whether to approve or reduce the prices to the lowest price of the referenced countries.
The Ministry of Health is responsible for the registrations and approvals regarding medicines and medical devices in Egypt through the Drug Policy and Planning Center and the Central Administration for Pharmaceutical Affairs in Egypt.
Reimbursement of drugs, biologicals, and medical devices:
MOHP’s facilities and Health Insurance Organizations follow the reimbursement process provided by MOHP. There are other institutions or ministry-affiliated public facilities follow MOHP regulations but have their own budget and autonomy.
Regarding the private sector entities, they have to abide by the MOHP healthcare standards and regulations, as they do not have to follow the same reimbursement regulations at the MOHP. The procurement department is responsible for setting the tender drug list and reimbursement price, which is published and distributed to all MOHP facilities. Each hospital or primary care facility with a plausible budget can purchase their drugs directly from the drug manufacturers or wholesalers according to the price specified in the tender drug list (No negotiations).
3. What are the steps to obtain authorization to develop, test, and market a product?
A variation application details a proposed change to approved documentation, providing a formal means by which the approved license details held by the Competent Authorities for a given medicinal product can be updated.
Types of variation such as follows: Variation department approval (VDA): They need prior approval by the variation department (VDA) before implementation;
Variation committee approval (VCA): They need prior approval by the variation committee (VCA) before implementation;
Technical committee approval (TCA): They need to be approved by the technical committee (TCA) before implementation;
Requirements to be fulfilled according to the type of change in the guidelines:
- Notification (N);
- Analysis inspection Department (AI);
- Analysis registration Department (AR).
- Accelerated (6M);
- 6M + long-term stability.
- None (DN);
- Comparative In-Vitro dissolution in most suitable medium (D1);
- Comparative In-Vitro Dissolution at three different PH media (1.2/4.5/6.8) and most suitable medium (D3/4);
- Bioequivalence study (BE).
D) Pricing (P)
N.B: In some cases, request within reporting category VDA can be issued to VCA if needed according to file case.
4. What are the approximate fees for each authorization?
The approximate fees for marketing application form is EGP 10,000.
The registration fee is EGP 1000 for each “Application Form”; the fee is non-refundable.
5. For how long are marketing authorizations/registrations valid? How are marketing authorizations/registrations renewed?
The registration is valid for 10 years starting from the day of obtaining the approval of the Technical Committee for Pharmaceutical Control, and the renewal procedures shall be renewed at the CAPA during the last year of its validity shall be applied at the beginning of the last year from the tens the applicant shall apply for renewing the registration to the General Authority for Registration. While the registration of the biological products, serums and vaccines are re-registered every 5 years according to a request submitted by the product owner to the CAPA as per Decree 297 of the year 2009.
6. How does the authorization process differ between brand-name products and generic products? Are there differences for local manufacturers versus foreign-owned manufacturers?
According to Decree No. 425 of the year 2015, in order for a pharmaceutical company to market and sell drug products under a brand-name the company shall firstly obtain approval from the Food and Drug Administration (FDA) by submitting a new drug application and a documentation shall include all data to establish drug’s clinical safety and efficiency. Moreover, studies will be performed to determine the characteristics of the drug dosage form, including the manufacturing process, drug stability, purity, strength, and how it dissolves. Once the drug receives FDA approval, the innovator company can then exclusively market and sell this ‘brand-name’ product for as long as the company has patent protection.
The “Box” system in the authorization of Pharmaceuticals in Egypt must include 12 products, in which one of them must be a brand-name product and the rest (eleven) are generic products.
Yes, there are differences. The authorization process of the local manufacturers differs from the foreign owned manufacturers.
The locally manufacturers’ authorization procedures will be as follows:
In accordance with the standards of the World Health Organization, a minimum of 10% of the production of Pilot Batch volume shall be complied with in the presence of an inspector from the General Directorate of Inspection. This operation shall not be carried out in the local market at all. The registration procedures shall be completed according to the installation statement on which the production was based. For the next steps:
- Take off samples through Pharmaceutical Inspection from the “Pilot Batch” for analysis at the National Organization for Drug Control and Research. The applicant shall submit the file of the analysis to the above-mentioned authority containing the required documents and attachments for the analysis file specified in Annex No.8, the committee is obliged to issue the analysis results within 60 working days form the date of the submitting of the file.
- Provide the accelerated stability study for a period of six months on the Pilot batch for evaluation by the scientific committee to evaluate the stability studies. The evaluation shall be within 60 working days from the date of presenting the stability study file.
- In cases where it is necessary to study availability, bioequivalence or solubility rate according to the rules and procedures for conducting studies of availability, bioequivalence and melting rate studies, samples are drawn by the General Administration for Pharmaceutical Inspection to be sent to the approved availability and bioequivalence centers of the administration and the evaluation of the study is conducted within 30 working days of the date of submission of the study.
For imported drugs, the procedures will be as follows:
Submission of the analysis file to the registration department of the National Organization for Drug Control and Research containing the required documents and attachments for the analysis file specified in Annex No.8, the committee is obliged to issue the analysis results within 60 working days form the date of submitting the file. For the Pharmaceutical products that have a certificate of registration and trading from one of the reference countries approved by the Technical Committee for Pharmaceutical Control, submit the file of the analysis to the National Organization for Drug Control and Research (Registration Department).
7. How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug +biologic + device) regulated?
There are no regulations in Egypt that regulate the combination of biologicals separately. The general regulations and Laws of the pharmaceutical products and medical devices may apply. However, the combinations of drugs are registered at the CAPA unless the combinations of the product consists of pharmaceuticals and medical devices, then, in this case, each component will be registered separately depending on its nature.
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?
Yes, the regulatory regime is comparable with the US Food and Drug Administration or the European Medicines Agency as the Egyptian Drug Authority (EDA) consists of Central Administration of Pharmaceutical Affairs (CAPA), National Organization for Drug Control and Research (NODCAR) & National Organization for research & Control of Biologicals (NORCB), each department monitors and has its own functions.
CAPA has a department, which is specialized in the inspection of the pharmaceutical factories. Such department inspects factories in order to ensure the compliance of the factories with the GMP of the WHO and the local regulations.
9. What is the potential range of penalties for noncompliance?
In the case of the inspection department finding a violation or non-compliance, the department will cancel or suspend the license.
10. Is there a national healthcare system? If so, how is it administered and funded?
Yes, there is the General Organization for Comprehensive Health Insurance Scheme, which is regulated by the Law No. 2 of the year 2018.
It is administrated by the Board of Directors of the Organization according to Article 6 of the said Law. Whereas the BOD is the supreme governing body of the Organization, running its affairs, and formulating and implementing such policies necessary for achieving its purposes and goals. Moreover, it shall have the authority to take final decisions without the need for approval of any further entity.
The Organization’s resources consist of:
- The Share of the insured and dependents;
- The Share of Employers;
- Investment yield of the Organization’s funds;
- Obligations of the public treasury for the poor;
- Charges of other services delivered by the Organization as determined by the BOD, apart from the charges stipulated in this law;
- External and domestic grants and loans contracted on by the government to the benefit of the organization pursuant to the rules established in this regard;
- Donations, assistances, contributions, and bequests which the organization’s BOD may decide to accept pursuant to the rules established in this regard;
- Other sources:
i. 75 piasters per a pack of cigarettes sold in the local market, whether the cigarettes were produced locally or abroad. Such amounts shall be increased every 3 years by 25 piasters until it reaches 150 piasters.
ii. 10% of the price of every sold unit of tobacco derivatives, apart from cigarettes.
iii. 1 EGP is collected for every vehicle passes on highways that are subject to these fees – collection system.
iv. 20 EGP for every year when issuing or renewing a driving license;
v. 50 EGP for every year when issuing or renewing license for vehicle for capacity of less than 1.6 liters;
vi. 150 EGP for every year when issuing or renewing a license for a vehicle of a capacity 1.6 liters and less than 2 liters;
vii. 300 EGP for every year when issuing or renewing license for a vehicle with a capacity of 2 liter or more;
viii. An amount ranging between 1000 and 15000 EGP when medical clinics, therapeutic centers, pharmacies and pharmaceutical companies, contract with the Scheme;
ix. 1000 EGP for every bed when licensing hospitals and medical centers;
x. Solidarity contributions of 0.0025% of gross annual revenues of sole proprietorships and companies, regardless of their type or legal systems governing them, as well as public economic authorities. In application of the Income Tax Law, Solidarity Contributions isn’t considered deductible costs;
xi. 50% of the revenues collected under self-resources development regulations for hospitals efficiency improvement, issued by Minister of Health Decree No. 239 of the Year 1997 and 200 of the year 2002;
xii. A stamp duty of 5 EGP in the name of the Scheme to be affixed to the application submitted to the Organization, the Care Organization and Accreditation and Control Authority.
11. How does the government (or public) healthcare system function with private sector healthcare?
The HIO covers the governmental employees and school-age children, was created decades ago in order to provide health care and insurance to the citizens. However, it was never implemented. Under the new universal health coverage, the plan is to reinstitute the role of HIO at the provider of insurance in care of all Egyptians. The increased premiums and co-payments for universal coverage consider the Employees salary range and the rise in health care services and prices. The CCO operates in specific governorates and contracts with other entities to provide care. Other public governmental entities – such as university hospitals and clinics, ministry – affiliated hospitals and clinics (e.g. military and railway hospitals), and institutions affiliated hospitals (e.g. EgyptAir hospitals and clinics) provide healthcare services for their members and population at large at a reduced fee. The Teaching Hospitals and Institute Organization (THIO) provides primary, secondary and tertiary services. Both of these entities have self-governance abiding by the MOHP regulations.
While the private sector includes several private insurance organizations as well as a network of outpatient clinics and hospitals. There are also health facilities run by religious entities and NGOs as a charity service. The private sector has its own set of regulations and standards. Some are the same as those for the public sector and some may differ. Private insurers and providers negotiate prices with drug manufacturers but are not involved in the drug evaluation process.
12. Are prices of drugs and devices regulated and, if so, how?
Yes, prices of drugs and devices are subjected to the compulsory pricing and determining the profits Law No.163 of the year 1950 and Law No. 113 of the year 1962 regarding the reorganization of the import, manufacture, and trade of medicines, supplies and medical chemicals.
The prices of pharmaceuticals are regulated through issued ministerial decrees issued by the Ministry of Health.
The Ministry of Health issued Decree No. 373 of the year 2009, which applies the lowest customer price available in any country where pharmaceuticals are traded with a 10% discount on the original price, years later, the Ministry of Health issued decree No.499 of the year 2012, the prices are determined during the registration process.
13. How are drugs and devices used by patients paid for? What roles do public and private payers play?
The drugs and devices used by patients are paid in accordance to the healthcare system and the pharmaceutical groups or medications that the specialized scientific committees and the organization have specified.
The General Organization for Comprehensive Health Insurance Scheme (GOCHIS) provides medical services and products to the public for nominal value at the governmental hospitals and pharmacies that are run by the MOH and the Ministry of Higher Education and Scientific Research. Such value covers a certain level of services and products. However, GOCHIS might approve certain medical services and products for free in certain cases. In case of private insurance, funds allow patients to receive free medical services and products from certain hospitals and pharmacies, which will be reimbursed by the funds.
14. Who dispenses drugs and devices to patients and how are those dispensers compensated?
Pharmacists registered at the Ministry of Health. The costs of the medical services or products will be reimbursed to the Pharmacists by the public or private insurance entities.
15. What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety?
Pharmacists cannot dispense drugs without a medical prescription and shall not distribute drugs which are not registered at the Ministry of Health.
A fine penalty not less than twenty thousand pounds and not exceeding fifty thousand pounds will be imposed to those who brought in, or produced with the aim of trading, or sold, or offered for sale, any of the medicines or the medical preparations and requisites for which there was no decree from the Minister of Health to use or circulate as well as on each one who would sell or offer for sale any of the medical requisites of unilateral use, as determined by a Decree from the Minister of Health, despite their previous use.
If the crime has been committed by the owner of a pharmaceutical organization or by whoever has been entrusted its management, a further infliction of the penalty of closure for a period not less than three months and not more than one year shall be sanctioned in addition to the penalty referred to.
In case of recidivism, the two minimum and maximum limits of the fine and closure stipulated upon under this Article shall be doubled.
Regarding the data protection responsibility on the dispensers, there are no data protection laws or regulations in Egypt, however, the Code of Ethics means that Doctors cannot disclose a patients’ secrets that have been disclosed to him due to his profession unless certain cases are applied. Moreover, the Penal Code prohibits the disclosure of patients’ secrets by physicians, pharmacists, nurses and midwives.
Concerning the safety of the patients, as per the Code of Ethics, the Doctor must warn his patients to take all the precautionary means and to guide them of the consequences in case of non-compliance with his instructions. The Doctor may request the signatures of his patients.