Lead Author: Olatundun Lawal
Additional Authors: Ademola Adelekan, Adetona Motunrayo, Philomena Omoregie
Organizations: Public Health Promotion Alliance
The effect is that the overall patent incidence is low and yet access to needed medicines has remained unattainable. Pharmaceutical patents therefore do not necessarily create monopoly pricing power beyond the patentee’s exclusive rights for that limited period of time. This is further reinforced by the fact that the patent is to an extent limited due to the therapeutic competition during the life of the patent and generic competition after the expiry of the patent. However, with respect to mid or low income vis-à-vis high income developing countries, it has been shown that patent ‘does not have a measurable impact on real or normal prices of existing drugs’.
In Nigeria, compared with other West African countries, a huge percentage of patents granted by the Patent Registry belong to foreigners. Nigeria has not leveraged on the existing international instruments either through Article 31 of TRIPS Agreement as expanded under Doha or the Patent and Designs Act both of which allow the use of patent by government or compulsory licensing to address the dire health challenges in the country. The National Health Bill is a quantum leap in terms of defining the new health policy direction that guarantees access to medicines, among the wider objectives of national health care delivery system. That guarantee in the Bill can be further strengthened with the incorporation of specific provision for use of patents by government authority in order to ensure urgent supplies of medicines in extreme cases of emergency. This will also bring it in line with that provision in the Patent Act as well as international best practice. Establishment of a national drug policy as a common framework to solve problems in pharmaceuticals and establishment and implementation of the national health equipment policy for Nigeria are therefore recommended for addressing the problem
Amir Attaran’s study on the patent status of 319 of WHO Essential Medicine List (EML) drugs in sub-Saharan African countries, including the mid-income developing countries, covering a population of over 4.6 billion people with the majority living in developing countries found only 17 essential drugs were patented. The effect is that the overall patent incidence is low and yet access to needed medicines has remained unattainable . Consequently, Professor Attaran drew the conclusion that “patents cannot cause essential drugs to be inaccessible in many developing countries because they do not exist 98.6% of the time” in those countries with the exception of South Africa, because of its market structure.
In the 2001 Survey of patents on 15 anti-retroviral drugs in 53 African countries, it was also found that “these anti-retroviral drugs are patented in few African countries.
. . and that in countries where anti-retroviral drugs patent exist, generally only a small subset of anti-retroviral drugs are patented”. Furthermore, in countries with high HIV prevalence on patents many anti-retroviral do not exist or are not enforced . That statistics would appear to cast a shadow of doubt on the affirmation that patent is responsible for lack of access to medicines. The same analogy appears to hold in the terms of patent structure itself having regard to the nominal life of the patent, which is 20 years, but in practice does not exist beyond 10 years particularly in relation to pharmaceuticals considering the long years of research and development process in its actual working. In that regard, pharmaceutical products may have its patent expire only about 8 years after it is marketed after which generic competitors can enter the
market and engage in price competition, which usually results in lower prices, even lower with multiple generic competitors producing competing versions of the drugs.
From that perspective, pharmaceutical patents therefore do not necessarily create monopoly pricing power beyond the patentee’s exclusive rights for that limited period of time. This is further reinforced by the fact that the patent is to an extent limited due to the therapeutic competition during the life of the patent and generic competition after the expiry of the patent.
However, with respect to mid or low income vis-à-vis high income developing countries, it has been shown that patent ‘does not have a measurable impact on real or normal prices of existing drugs’. A 1998 study reviewed the prices of eight drugs in six different therapeutic classes across nine different countries, including countries with and without patent protection, the authors concluded that price movements of branded pharmaceutical product are generally not affected by changes in patent laws’ .
In Nigeria, compared with other West African countries, a huge percentage of patents granted by the Patent Registry belong to foreigners. The 1999 – 2002 data shows that of the 2,544 patents issued, 1,458 are foreign and 986 are to local applicants in which case some of the local grants are made under license from foreign owners . Nigeria has not leveraged on the existing international instruments either through Article 31 of TRIPS Agreement as expanded under Doha or the Patent and Designs Act both of which allow the use of patent by government or compulsory licensing to address the dire health challenges in the country.
TRIPS, Public Health and the Global Debate
The test of TRIPS’ regime for the protection of pharmaceutical patents in the context of promoting public health needs lies in the balance between maintaining a steady patent protection in order to spur the need for research and development on the one hand and a regime of public health which requires accessibility for pharmaceuticals at affordable prices for the wanting population. That test has continued to stretch the ability and the legitimacy of the TRIPS Agreement as a veritable instrument evidencing the global consensus for intellectual property and sustainable development including the ability of developing countries in particular to address their public health needs through a multilateral IP regime. The global debacle became more intense barely a decade into the TRIPS Agreement at the 4th WTO Ministerial Conference in November 2001 in Doha, Qatar. Resulting from intensive negotiations initiated in the TRIPS Council by the African Group, the now famous Doha Declaration sought to clarify the relationship between TRIPS and public health. The Doha Declaration therefore was the product of the discontent among developing countries against the TRIPS Agreement and the feeling that the Agreement constituted an ‘obstacle to development’ and in particular the pursuit of public health policies by developing countries . The discontent borders on the obstacle created by a twenty-year long patent regime for patent holders which, as alleged, is responsible for the absence of affordable medicines needed to combat communicable diseases in developing and African countries. Access to medicines particularly for HIV/AIDS pandemic that is ravaging the most productive population in these countries had become a grave concern to governments.
Public health conditions
Public health conditions have had the history of engaging national attention in a number of ways depicted in various government actions and programmes such as Roll Back Malaria or the establishment of specialized institutions targeted at specific area of special needs, such as the National Action Committee Against AIDS (NACA) in the wake of the HIV/AIDS pandemic or NAFDAC to regulate the use of foods and drugs. Nigeria has been ranked fourth in the world’s tuberculosis prevalence table and second in Africa, recording annual incidence of 311 cases per 160,000 population. Tuberculosis is reported as the leading cause of death among HIV infected people in Africa and that 1/3 of the 40 million people living with HIV/AIDS worldwide are co-infected with TB . India and Nigeria recorded the most cases of polio between 2000 and 2005 with about 2,971 reported cases. Over this period there were 2120 reported cases in Nigeria alone. The large scale internationally financed polio immunization programme for children between 0-5 years, provided the vaccines, which at some point was rejected in some parts of the country, has since 2006 nipped the epidemic in the bud. Nigeria confirmed the swine flu epidemic that first hit Mexico before spreading to the USA in 2008.
Addressing barrier Preventing access to medicines
It is significant to note that the solution to this problem does not lie alone with isolating the so called patent factor in addressing access to medicines, rather it lies in confronting the challenges brought about by the combination of other socio-economic, infrastructural, cultural and political factors that constitutes barrier to access, the discussion of which is not within the scope of this paper . As a developing country, Nigeria is faced with multi-faceted challenges; economic, political and technological which has negative effect on the provision of a sustainable healthcare delivery. Suffice to say that meeting some of those challenges involves building local pharmaceutical production and supply capacity in order to obviate the necessity of invoking the patent law measures to address this critical public health situation. Even at that, the official use is available as an extra-ordinary measure where public health infrastructure is stretched to the limits. The National Health Bill is a quantum leap in terms of defining the new health policy direction that guarantees access to medicines, among the wider objectives of national health care delivery system. That guarantee in the Bill can be further strengthened with the incorporation of specific provision for use of patents by government authority in order to ensure urgent supplies of medicines in extreme cases of emergency. This will also bring it in line with that provision in the Patent Act as well as international best practice.
Implementation strategies for addressing the problem
Establishment of a national drug policy as a common framework to solve problems in pharmaceuticals
Experience in many countries has shown that the complicated and interdependent problems associated with quality and use of essential drugs can best be addressed within a common framework, as piecemeal approaches can leave important problems unsolved and often fail. In addition, the different policy objectives are sometimes contradictory, and so are the interests of some of the stakeholders. On the basis of this experience, WHO recommends that all countries formulate and implement a comprehensive national drug policy (NDP). A national drug policy is a commitment to a goal and a guide for action. It expresses and prioritizes the medium- to long-term goals set by the government for the pharmaceutical sector, and identifies the main strategies for attaining them. It provides a framework within which the activities of the pharmaceutical sector can be coordinated.
A functional national drug policy is needed in Nigeria for the following reasons: (i) to present a formal record of values, aspirations, aims, decisions and medium- to long-term government commitments; (ii) to define the national goals and objectives for the pharmaceutical sector, and set priorities; (iii) to identify the strategies needed to meet those objectives, and identify the various actors responsible for implementing the main components of the policy; (iv)to create a forum for national discussions on these issues. The drug policy should be able to accomplish the following:
(a). Establish norms and standards: Set, validate, monitor, promote and support implementation of international norms and standards to promote the quality of medical products, and ethical, evidence based policy options and advocacy.
(b). Procurement: Encourage reliable procurement to combat counterfeit and substandard medical products, and to promote good governance and transparency in procurement and medicine pricing.
(b). Access and use: Promote equitable access, rational use of and adherence to quality products, through providing technical and policy support to health authorities, professional networks, consumer organizations and other stakeholders.
(c). Quality and safety: Monitor the quality and safety of medical products, by generating, analysing and disseminating signals on access, quality, effectiveness, safety and use.
(d). New products: Stimulate development, testing and use of new products, standards and policy guidelines, emphasizing a public health approach to innovation, and on adapting successful interventions, with a focus on essential medicines that are missing for children and for neglected diseases.
Establishment and Implementation of the National Health Equipment Policy for Nigeria
The implementation of the National Health Equipment Policy for Nigeria should be by legislation, which should include the establishment of a regulatory body. To ensure success, the strategies should take into account, expressed fears and needs of all interest groups. This should be followed by the drawing up of regulations for carrying out the provisions of the law. The strategies are to be considered under the following:
a. Inventory of Medical Equipment: Although a large proportion of medical devices are not functioning in most health care setting in Nigeria, the exact number, brand and location are not known. Therefore the first step is to take inventory of all the medical equipment in a given health care facility.
b. Standardization of Medical Devices: This strategy is expected to solve the existing problem of a wide variety of equipment models imported from a number of countries, which made maintenance difficult. Foreign manufacturers/suppliers with representatives in Nigeria should be preferred.
c. Selection of Medical Devices (Technical Specification): Selection of medical devices should be based on the disease pattern in the country, their suitability for tropical environments and the staff available to operate them.
d. Procurement System: The procurement process should be properly planned and managed. This is because equipment supply has to be coordinated with the construction of a new facility or the modification of an existing one for proper installation.
e. Regulatory System and Registration of Medical Devices: The Body should regulate medical devices either by direct government involvement, third party certification or a combination of both methods.
f. Human Resource Development (Training & Re-training): The Body should be responsible for funding the Training Centres, development of the curricula in conjunction with Federal Ministry of Education. The Training Centres should serve a dual purpose that is teaching and conducting repairs of medical devices.
g. Indigenous manufacturing and servicing of Medical Devices: The way out of our present overdependence on foreign technology is to develop local capability for equipment production. Manufacturing of certain categories of medical devices locally within stipulated standards should be promoted and encouraged.
h. Maintenance of Medical Devices: The regulatory body should all promote and encourage a maintenance culture. Health Care Institutions only pay attention to maintenance when there is a major equipment breakdown.
i. Monitoring and Evaluation: The Agency should conduct monitoring and evaluation activities periodically to ensure that the set objectives are achieved.
Bibliography and References
1. Amir Attaran: How Do Patents and Economic Policies Affect Access to Essential Medicines in Developing Countries, Health Affairs, Vol. 23, No. 3, pp.155-66.
2. Amir Attaran & Lee Gillespie-White: Do Patents for AntiRetroviral Drugs Constrain Access to AIDS Treatment in Africa, Journal of the Americas Medical Association, Vol. 286, No. 15, 17 Oct. 2001, p.1886.
3. Eric Noehrenberg: The Realities of TRIPS, Patent & Access to Medicines in Developing Countries cited in The Intellectual Property Debate, Perspectives from Law, Economics & Political Economy, M. Pevez Pugatch (Ed.) at 170, 173. Eric Noehrenberg.
4. Richard Rozek and Ruth Berkontz: ‘The effects of Patent Protection of the Prices of Pharmaceutical Products; is Protection raising the Drug Bill in Developing Countries National Economic Associates, January 1998.
5. Ikechi Mgbeoji: TRIPS & TRIPS – PLUS Impacts in Africa in Intellectual Property, Trade & Development, Strategies to Optimized Economic Development in a TRIPS –PLUS Era, Daniel Gaervais (Ed.) 259, 280.
6. P. Andorran, Medicaments sans Frontiers? Clarification of the Relationship between TRIPS & Public Health resulting from the WTO Doha Ministerial Declaration, J.W. IP, Vol 5, No. 1; January 2002 @ 5.
7. H.S. Aghanwa & Gregory E. Erhabor: Demographic Socio-Economic Factors in Mental Disorders Associated With Tuberculosis in South-West Nigeria, Journal of Psychosomatic Research, Vol. 45, Issue 4, pp. 353-360 (October 1998).
8. Adewole Adedeji: Combating the Scourge of HIV/AIDS in SubSaharan Africa; Beyond Intellectual Property Rights, Vol VI, Issue I (2008)