The role of intellectual property rights on access to medicines in the WHO African region: 25 years after the TRIPS agreement.

BACKGROUND: It is now 25 years since the adoption of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the same concerns raised during its negotiations such as high prices of medicines, market exclusivity and delayed market entry for generics remain relevant as highlighted recently by the Ebola and COVID-19 pandemics. The World Health Organization's (WHO) mandate to work on the interface between intellectual property, innovation and access to medicine has been continually reinforced and extended to include providing support to countries on the implementation of TRIPS flexibilities in collaboration with stakeholders. This study analyses the role of intellectual property on access to medicines in the African Region. METHODS: We analyze patent data from the African Regional Intellectual Property Organization (ARIPO) and Organisation Africaine de la Propriété Intellectuelle (OAPI) to provide a situational analysis of patenting activity and trends. We also review legislation to assess how TRIPS flexibilities are implemented in countries. RESULTS: Patenting was low for African countries. Only South Africa and Cameroon appeared in the list of top ten originator countries for ARIPO and OAPI respectively. Main diseases covered by African patents were HIV/AIDS, cardiovascular diseases, cancers and tumors. Majority countries have legislation allowing for compulsory licensing and parallel importation of medicines, while the least legislated flexibilities were explicit exemption of pharmaceutical products from patentable subject matter, new or second use of patented pharmaceutical products, imposition of limits to patent term extension and test data protection. Thirty-nine countries have applied TRIPS flexibilities, with the most common being compulsory licensing and least developed country transition provisions. CONCLUSIONS: Opportunities exist for WHO to work with ARIPO and OAPI to support countries in reviewing their legislation to be more responsive to public health needs.

Readiness of ethics review systems for a changing public health landscape in the WHO African Region.

BACKGROUND: The increasing emphasis on research, development and innovation for health in providing solutions to the high burden of diseases in the African Region has warranted a proliferation of studies including clinical trials. This changing public health landscape requires that countries develop adequate ethics review capacities to protect and minimize risks to study participants. Therefore, this study assessed the readiness of national ethics committees to respond to challenges posed by a globalized biomedical research system which is constantly challenged by new public health threats, rapid scientific and technological advancements affecting biomedical research and development, delivery and manufacture of vaccines and therapies, and health technology transfer. METHODS: This is a descriptive study, which used a questionnaire structured to elicit information on the existence of relevant national legal frameworks, mechanisms for ethical review; as well as capacity requirements for national ethics committees. The questionnaire was available in English and French and was sent to 41 of the then 46 Member States of the WHO African Region, excluding the five Lusophone Member States. Information was gathered from senior officials in ministries of health, who by virtue of their offices were considered to have expert knowledge of research ethics review systems in their respective countries. RESULTS: Thirty three of the 41 countries (80.5 %) responded. Thirty (90.9 %) of respondent countries had a national ethics review committee (NEC); 79 % of which were established by law. Twenty-five (83.3 %) NECs had secretarial and administrative support. Over 50 % of countries with NECs indicated a need for capacity strengthening through periodic training on international guidelines for health research (including clinical trials) ethics; and allocation of funds for administrative and secretariat support. CONCLUSIONS: Despite the existing training initiatives, the Region still experiences a shortage of professionals trained in health research ethics/ethicists. Committees continue to face various capacity needs especially for evaluating clinical trials, for monitoring ongoing research, database management and for accrediting institutional ethics committees. Given the growing number of clinical trials involving human participants in the African Region, there is urgent need for supporting countries without NECs to establish them; capacity strengthening where they exist; and creation of a regional network and joint ethical review mechanisms, whose membership would be open to all NECs of the Region.

National health research systems in the WHO African Region: current status and the way forward.

BACKGROUND: A number of resolutions of the World Health Assembly and the WHO Regional Committee for Africa call upon African countries and their development partners to make the required investments in national health research systems (NHRS) to generate knowledge and promote its use in tackling priority public health challenges. Implementation of these resolutions is critical for Africa to progress with the rest of the world in achieving the post-2015 health sustainable development goal. This study assesses the current status of some NHRS components in the 47 countries of the WHO African Region, identifies the factors that enable and constrain NHRS, and proposes the way forward. METHODS: To track progress in NHRS components and for comparison, a questionnaire that was used in NHRS surveys in 2003 and 2009 was administered in all 47 countries in the African Region. The national health research focal persons were responsible for completing the questionnaire, which had been hand-delivered to them by the WHO country office staff in charge of research, who also briefed them on the survey, went through the questionnaire for clarity, and sought their informed consent. RESULTS: All the 47 countries responded to the questionnaire, but some did not answer all questions. Of the countries responding to various questions 49 % (23/47) had a national health research policy; 47 % (22/47) had a health strategic plan; 40 % (19/47) had legislation governing research; 53 % (25/47) had a national health research priority agenda; 51 % (24/47) reported having a functional NHRS and a national health research management forum; 91 % (43/47) had an ethical review committee; 49 % (23/47) had hospitals with ethical review committees to review clinical research proposals; 51 % (24/47) had a scientific review committee; 62 % (29/47) had health institutions with scientific review committees; 83 % (39/47) had a national health research focal point; 51 % (24/47) had a health research programme; 55 % (26/47) had a national health or medical research institute or council; 93 % (41/44) had at least one university faculty of health sciences that conducted health research; and 33 % (15/46) had a knowledge translation platform. Forty-seven percent of countries reported having a budget line for research for health in the ministry of health budget. Between 2003 and 2014, the countries with a functional NHRS increased from 30 % to 51 %. CONCLUSION: Compared with 2003 and 2009 surveys, our survey found many countries to have made progress in strengthening some of the functions of their NHRS. However, there remains an urgent need for countries without NHRS to establish them and for others to improve the functionality and efficiency of every NHRS component. This is necessary for the national governments to effectively execute their leadership and governance of NHRS and to create an enabling environment within which research for health can flourish.