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30 years of TRIPS and 20 years of patenting in Egypt: Why access to medicines might still be a challenge In the face of strict, internationally imposed patenting requirements, Egypt continues to prioritise affordable medicines for its people. Heba Wanis DRUG policies in Egypt have historically prioritised access and affordability. To this end, two key measures were established in the mid-20th century amid the growth of an ambitious pharmaceutical industry: a government (compulsory) drug pricing mechanism, and a patent law (132/1949) which protected the pharmaceutical process but not the product. Until the early 2000s, Egyptians enjoyed low medicine prices, thanks to government controls and competition from generics, with a fair number of producers per product. Given the high proportion of spending on health and medicines in Egypt paid for out of pocket, currently estimated to be 62.75%,1 a no-product-patent industry combined with price controls meant that medicines remained accessible. When the World Trade Organization (WTO)’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) came into being, Egypt prepared itself for the new global paradigm starting from 2005 when the Agreement would come into force after a five-year transition period. The now famous Law 82/2002 on the Protection of Intellectual Property Rights has deliberately incorporated all possible safeguards against potential public health implications of the new Agreement, benefiting from the far-sightedness and expertise of its drafters. The Law applied the minimum protection standards of the TRIPS Agreement and incorporated all its flexibilities, interpreting it in accordance with the principles and objectives stated in Articles 7 and 8 of the Agreement. The flexibilities related to public health protection include exceptions and limitations to patentability (Article 2 of the Law); compulsory licensing in cases of patent misuse or failure of exploitation (Articles 23 and 24); international exhaustion; and regulatory review (Bolar) exception (Article 10). The Law does not allow for patent linkage as it clearly demarcates the mandates of the patent office vis-à-vis the drug regulatory authority, so that the drug registration process is independent of the patent status. Nevertheless, transnational pharmaceutical corporations often exert pressure on regulatory authorities to prevent the registration of generic versions of their marketed products during their patent term, with some of the cases taken to court by the generic companies.2 Similarly, the Law does not recognise data exclusivity as a form of protection for test data submitted for registration in order for the regulatory authority to register generic versions of medicines utilising previously submitted clinical trial results. Test results are, however, protected by rules of unfair competition, but are not to be withheld when generic medicines need to be registered. Meanwhile, the Egyptian Patent Office has gained the global reputation of being a proponent of public health and development. Over the years, its team of pharmaceutical examiners has accumulated expertise based on thorough understanding of both international and national law. The Office applies absolute novelty as a patentability criterion, thus setting high standards as to which patent applications pass the examination process. Intellectual property (IP) law and examination practices in Egypt both create ample policy space for the generic-medicine industry to flourish. This was clearly demonstrated when the local pharmaceutical industry contributed to the success of Egypt’s viral hepatitis treatment programme following the launch of the Plan of Action for the Prevention, Care and Treatment of Viral Hepatitis 2014–2018. At the time, the US Food and Drug Administration (FDA)’s approval of sofosbuvir (SOF) in December 2013 marked new hope for treating the disease. A longstanding public health problem in Egypt, viral hepatitis C chronic infection prevalence rates had reached 10% among 15–59–year–olds and more than 25% among 50–60–year–olds by 2012, with an estimated 150,000 new infections annually, making the country a key global market for SOF. The deal with the manufacturer, the US-based pharmaceutical giant Gilead, was set at $300 per box, that is, $900 per 12-week treatment course – low compared with the exorbitant globally announced price of $84,000 at the time, and yet too high for Egypt’s modest national health budget, and certainly much higher than the calculated manufacturing cost of $68–136.3 The agreed price was valid until the Patent Office issued a decision rejecting the SOF patent application, indicating that the ‘invention’ failed to meet the patentability criteria of novelty and inventive step. This decision opened wide the door for local generic producers which produced SOF among other direct-acting antivirals (DAAs) at fractions of the global prices, thereby enabling the medicine to be made more accessible to the country’s hepatitis patients, both under the national treatment programme or privately for those who could afford to buy it out of pocket. Patent examination practices in Egypt not only play a crucial role in protecting the population from unnecessary pharmaceutical patents, which would lead to expensive medicines, but also create a wide operational space for local pharmaceutical companies with research and development (R&D) capacity to expand their portfolio. There is a great, as yet untapped, potential in the information made available in all patent applications filed and in a broad public domain. This goldmine of patent information has been strongly promoted by the Egyptian Patent Office among researchers in academic circles and in the local generic industry. Compulsory licensing of patented medicines is another means to enhance their accessibility and affordability. While compulsory licensing is provided for by the IP Law 82/2002 (Articles 23 and 24) as a protection for public health, it has never been utilised. One reason is purely procedural: the 2002 Law states that a compulsory licence is to be approved by a Ministerial Committee, but this Committee was only established in 2020, that is, 18 years after the Law. The Committee is mandated with approving compulsory licences issued by the Patent Office; determining the financial rights of the patent holder when compulsory licences are issued; and revoking of patents. Patents are only one, albeit significant, determinant of access to medicines. Pricing policy; local production capacity; health insurance coverage and private spending on health are among the other factors. Despite the high out-of-pocket expenditure on health (62.75%, as mentioned above), of which nearly half goes to medicines, Egypt’s per capita pharmaceutical expenditure remains among the lowest in the Middle East and North Africa region, and is expected to decrease. The demand for generic medicines is surging in the market.4 Such trends cannot be examined in isolation of the economic situation which has had an impoverishing effect on whole segments of the population. Despite the claimed self-sufficiency in medicines, Egypt is a net drug-importing country, with imported finished products comprising 73% of products on the market, and 90–95% of the components of locally produced medicines being imported.5 Arguably, certain therapeutic groups such as oncology medicines and biological products continue to be primarily imported, hence exhibiting high prices. There are local pharmaceutical companies with far-sighted R&D plans. Such companies have developed their own strategies to navigate local, regional and global markets through ambitious partnerships and pharmaceutical alliances with resulting voluntary licensing agreements and joint technological ventures. However, on the domestic front, there continue to be challenges as the relatively newly established Egyptian Drug Authority, now operating independently from the Ministry of Health, reviews and updates its mandate after the restructuring of national drug regulation and national drug procurement.6 While operating in a complex environment, the pharmaceutical sector in Egypt has demonstrated resilience, thanks to its large manufacturing base and to legislative safeguards. In the period since the TRIPS Agreement came into force, time and experience have shown that the national IP regime has still got wide, as yet unutilised, policy space for the pharmaceutical industry to build upon, including a vast public domain created by patent information and rejected patents. These are learning and production opportunities for local manufacturers whose presence and sustainability in a developing-country market are fundamental for access and affordability of medicines. Heba Wanis is a researcher in public health with the Third World Network. Her work focuses on access to medicines, pharmaceutical policy, drug regulation, pricing and intellectual property. Heba holds a Master of Public Health degree from the University of Edinburgh and an MA in Community Psychology from the American University in Cairo. Notes
*Third World Resurgence No. 363, 2025/2, pp 41-43 |
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