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The President of the Egyptian Drug Authority (EDA) is has become a Member of the Compulsory Licensing Ministerial Committee (“CLMC”)

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) has become a member of the CLMC formed by 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 regulations of IP law articles No. 36 -43. The members of CLMC as outlined by PM decree No. 251/2020 issued back in January 2020 were:

the Minister of Higher Education,

the Minister of Supply and 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 IP Law is examining CL requests for the exploitation of patented inventions and to giving approval or rejection 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 the 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..); as well as medical devices, dental supplies, and 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 appoint 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

Scientific Counsel

+201223667746

gat@id.com.eg

To Egyptian patients with affordable prices and to open more doors for export opportunities    . Therefore, it is crucial that local companies recognize the value of biotechnology and be courageous to invest in this field. Recently, several Egyptian pharmaceutical companies in Egypt are daring to start several massive biotechnological projects:

EIPICO (Egyptian International Pharmaceutical Industries Company):

Furthermore, to meet the company’s strategic development plans, establish itself as the manufacturer of the first biosimilar, and reinforce its leading position in the region, EIPICO is planning to build a new factory, “EIPICO 3” with investments of more than EGP 1.4 bn. The new manufacturing facility, a green-field establishment next to the current site in the 10th of Ramadan City, Egypt, will be designated for biosimilar products and the first of its kind in Egypt and the MENA region. A significant milestone for EIPICO and the supply of biopharmaceutical products to the region, EIPICO will produce several biosimilar monoclonal antibodies and small protein products in the new facility. These products are manufactured from basic raw materials, including drug substance production and formulation, filling, inspection, and packing. EIPICO also plans to formulate, fill, inspect, and pack other products, such as insulin, in vials, and syringes. In addition, EIPICO is collaborating with Reliance Life Sciences, which is an Indian research-driven organization developing business opportunities in bio-therapeutics (plasma proteins, biosimilars, and novel proteins), pharmaceuticals (later-generation, oncology generics), clinical research services, regenerative medicine (stem cells therapies) and molecular medicine. Also, EIPICO cooperates with the multinational company Pharmadule (part of Morimatsu Industry Group), aworldwide international manufacturer of industrial modules and systems with its head office located in Stockholm and its branches in New Jersey, Shanghai, and Mumbai. EIPICO also has ambitious plans to start at the Suez Canal Free Zone a new active ingredient (API) Manufacturing facility “ARABAPI”, which is the first of its kind in Egypt.

Grifols Egypt for Plasma Derivatives: A joint venture company between the National Service Projects Organization (NSPO) and Grifols, a Spanish company established in 1909. By combining both organizations’ expertise, technology, and resources, this strategic partnership seeks to strengthen Egypt’s healthcare system by achieving self-sufficiency in plasma-derived medicines while reinforcing Grifols’ international expansion in the Middle East and Africa. The project’s scope entails initiating twenty plasma donor centres and establishing necessary manufacturing facilities to produce essential medicines. This includes testing and warehousing operations, a protein purification plant, and a plasma fractionation plant with a capacity of one million litres per year that is expected to double in the future.

Minapharm:

Launched in the late 1950s, Minapharm marked itself as Egypt’s first privately-owned pharmaceutical factory. This company already has several biotech products in the Egyptian market like Hirudin and Follitropin. Acknowledging the company’s development of sophisticated biotechnology platforms and its choice of strategic partnerships with Germany’s pharmaceutical sector, Minapharm is exceptionally well-placed to take advantage of an exponential increase in opportunities in Egyptian and other developing markets. Minapharm’s CEO considers the founding of tie-ups with German firms as a vital milestone. Minapharm got into a joint venture with Rhein-Biotech (now Dynavax Europe) as early as the 1990s, before the 2010 procurement of ProBioGen AG, a Berlin-based cellular engineering biotech expert. ProBioGen and Minapharm Pharmaceuticals announced the integration of ProBioGen’s subsidiary “MiGenTra” with its head office located in Berlin; while having access to  the Cairo site, which will house the prime manufacturing plant. The formation of MiGenTra speeds up ProBioGen’s 2030 growth roadmap. It displays that further growth is not restricted to the ongoing capacity increase but reveals several significant steps in the variation of ProBioGen’s business.

SEDICO (South Egypt Drug Industries Company):

SEDICO is one of Egypt’s pioneer pharmaceutical drug industries that produce insulin and biotechnology products. Situated in 6th of October City and having several biotech products. The company manufactures biotechnology products including insulin, streptokinase, angikinase, Follicle Stimulating Hormone (FSH), somatropin, erythropoietin, and Trastuzumab that are produced under the BGP Pharma ULC/Mylan license  in Canada -.

MUP (Medical Union Pharmaceuticals)

It was first established in 1984, owing to the cooperation of the Professional Syndicates Union. This company acquired the Eli Lilly insulin manufacturing facility in 6th of October City in 2016, which is considered the nucleus for starting a different line insulin product that it markets under the commercial name Insulinaegypt. In addition, the company has in its pipeline projects for enlarging the current manufacturing facility and adding more insulin dosage forms such as the cartridges and dispensing pens.

VACSERA /EGYVAC:

A producer of Vaccines and Sera in Egypt, being one of the leading blood banks in Egypt and the oldest manufacturer of vaccines in Africa and the Middle East. VACSERA’s mission is to produce, import, and market vaccines, sera, and biological products to secure society’s requirement of vaccines and sera with commitment to continuous development of all activities. More than one million doses of the VACSERA-Sinovac jab, the COVID-19 vaccine, had already been distributed within Egypt. VACSERA is also looking to expand and complete its unfinished projects; while taking into account that the most important is to provide a plan to produce retractable syringes.

EVA Pharma:

An Egyptian company that develops products that meet the health care needs of Egyptians. According to its CEO, their first introduction to biotech products will be the COVID-19 vaccine. According to EVA Pharma’s CEO, the ministries of higher education and agriculture will work on producing the viral antigen for the vaccine, which will be manufactured at Eva Pharma industrial complex following the standards of the Egyptian Drug Authority (EDA), the World Health Organization, and the US Food and Drug Administration.

Vaccine Valley:

It was established in 2006 as a dedicated facility for producing diverse types of veterinary vaccines. The factory is located in the sixth industrial zone and 6th of October city.

Dr. Gihan Taha

Scientific of Counsel, IP Department

+201223667746

gat@id.com.eg