The Prime Minister (PM) (Dr. Mostafa Kamal Madboli) issued on August 18th, 2021, the decree number 1967/2021 stating that the President of the Egyptian Drug Authority (EDA) is now a member of the Compulsory Licensing (CL) Ministerial Committee formed by the Decree 251/2020 . This Committee was established in compliance with articles 23 and 24 of the Egyptian IP law No. 82/2002 and the executive regulation of IP law articles No. 36 -43. The members of the Committee as outlined by the PM Decree No. 251/2020 that was issued back in January 2020 were:
- the Minister of The Higher Education,
- the Minister of Supply and the Internal Trade,
- the Minister of Health,
- the Minister of Trade and Industry and,
- the Head of The Competition Authority.
The role of this Committee according to the IP Law is examining CL requests for the exploitation of patented inventions and to give approval or denial decisions accordingly. The Egyptian Patent Office (EPO) is the authority that finally issues the CL as per article (23) of the Egyptian IP Law after acquiring the approval of the Committee .
Patents of pharmaceutical inventions (new molecules, new combinations, innovative dosage forms, novel synthesis pathways etc…) constitute the majority of patented inventions that are expected to be subject of a CL request by local generic companies. This is the reason of including the Minister of Health in the first version of the Committee’s structure. EDA is a public service authority that was established by the Law No. 151/2019 to replace the establishments concerned with all aspects of drugs and medical supplies including all kinds of pharmaceutical products (drugs, biological, vitamin supplements, nutraceuticals, herbal, cosmetics etc..); also medical devices, dental supplies, hospital equipment etc.. All aspects include but are not limited to registration, quality control, inspection of manufacturing facilities, imports, exports, chemical analysis, pricing, monitoring of drug shortages, examining clinical trials data, bioequivalence studies evaluation, follow up pharmacovigilance and so on. Consequently, the above decree is a necessary step to add the President of the EDA as an important member of the Committee when it comes to examining and discussing a request for CL in the pharmaceutical field.
Dr. Gihan Taha