Legal Development in the Medical Re

On 6 December 2017, Presidential Decree No. 605 of 2017 (the “Decree”)[1] was issued regarding the establishment of a medical centre the focus of which is the development of stem cell research (the “Centre”). The importance of stem cell research lies in the ability of these cells to self-renew or differentiate into various types of cells. This is medically imperative in terms of tissue repair and regeneration.

Background

The recent Decree presents an opportunity to discuss the legal framework governing scientific research in Egypt. The Egyptian Constitution states that 1% of Egypt’s GDP should be dedicated to research, while a 2013 study by the Ministry of Scientific Research stated that Egypt ranks 4^th among Middle East countries and 41^st globally when it comes to scientific research.[2] In March of 2017, the Minister of Higher Education and Scientific Research stated that the Ministry is working on a newly developed project to encourage collaboration in the field of scientific research in Egypt by creating a database that incorporates researchers from all institutions and sectors. Law No. 69 of 1973 regarding the Organization of Scientific Researchers in Scientific Establishments,^[3] regulates the work of scientific researchers in academic institutions. In addition, Decision No. 435 of 2006 issued by the Ministry of Health and Population regarding the Egyptian Code for the Evaluation of Clinical Trials of Biologics and Vaccines^[4] incorporates the National Guidelines and Regulations for Good Clinical Practice (GCP). This is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. The decree defines a medical institution as any public or private entity or agency or medical or dental facility where clinical trials are conducted. It also lists the requirements for an investigator to be qualified to investigate situations wherein trials violate the rights of their subjects. A recent trend in Egyptian legislation has also been to encourage training and scientific research. For instance, Investment Law No. 72 issued in May 2017 contains a provision on corporate social responsibility that encourages investors to support technical and vocational training, as well as scientific research, while exempting any amounts paid by the investor (up to 10% of annual profit) for these purposes from taxation under Income Tax Law No. 95 of 2005. Similarly, a provision under the Value Added Tax Law No. 67 of 2016 exempts training, education, and scientific research services from its scope.

The Recent Decree

The recent Decree creates the Medical Centre for Research on Medical Regeneration with the aims of contributing to the prospering of Egypt’s scientific research capabilities in the medical field. The Centre’s mandate includes:

• Researching and finding cures for various viruses and diseases.
• Undertaking research on stem cells that can be translated into effective application and useful implementation, whilst abiding with ethical and quality standards.
• Developing pharmaceutical productions and promoting the creation and production of pharmaceuticals according to the findings of medical regeneration.
• Developing and applying research projects, both independently and in collaboration with domestic and international researchers.
• Concluding agreements with other players in the field whether Egyptian or foreign.
• Operating as a national laboratory, and undertaking steps for international accreditation.

In terms of structure, the Centre’s board of directors is directly headed by the Chief of Staff of the Armed Forces, and comprised of six representatives of the Ministry of Defence, three representatives of the Ministry of Health, two representatives of the Ministry of Higher Education, and two representatives from the Ministry of Scientific Research. The Minister of Defence is to issue a decree forming the Centre’s board of directors every three years, and that term can be renewed with no specification of a limit to the number of renewals. Decisions taken by the board during meetings are not to be considered valid until they have been approved by the Minister of Defence. Moreover, according to the Decree, the Centre will be able to expand by establishing numerous branches upon a decision by the Minister of Defence.   [1] Presidential Decree No. 605/2017 establishing the Medical Centre for Research on Medical Regeneration, Official Gazette, Issue No. 48 (bis) (a), 6 December 2017. [2] Presentation by the Minister of Scientific Research before the United Nations’ Economic and Social Forum in Tanzania, 14 March 2013, available through this link. [3] Law No. 69/1973 on the Organization of Scientific Researchers in Scientific Establishments, Official Gazette, Issue No. 34, 23 August 1973. [4] Minister of Health and Population Decision No. 435/2006 on the Egyptian Record of Good Manufacturing Techniques for Biological Compounds, Serums, and Vaccines, Egyptian Gazette, Issue No. 7 (cont.), 11 January 2007.