Safiatou Simpore Diaz, Yolse (English Translation)

Lead Author: Safiatou Simpore Diaz
Organization: Yolse
Country: Switzerland

Abstract

Conversion of the patent department of the national intellectual property offices of least developed countries (LDC) into an innovation, technology and science office (ex. Sub-Saharan Africa).

Since LDCs have been released from their obligation to protect pharmaceutical patents and clinical trial data, we propose converting the patent department of the national intellectual property offices of LDCs into innovation, technology and science offices.  Their objective is to ensure national coherence to correct the incoherence at the global level.  They will be responsible for coordinating the following activities:
- The effective implementation of the transition period for LDCs.
- Leveraging flexibilities to promote access to essential medicines.
- Coordinating the different national stakeholders.
- Establishing a strategy for attracting foreign investors.
- Coordinating the national capacity building activities.
- Promoting the adoption of a Research and Development treaty (R&D).

Submission

Contribution of the NGO Yolse to the work of the United Nations Secretary-General’s High-Level Panel Group on Access to Medicines
February 28, 2015

1. Access to medical products, a right to health?
Today, access to essential medicines, to diagnoses and to vaccines is both a moral and a legal requirement. The world has technical and scientific means at its disposal allowing access to medicines to save human live; these means are widely available in developed countries. Conversely, these means are inaccessible in least developed countries, which have a greater need for them.
Access to medicines is the realization of a fundamental right to health recognized in various international and regional instruments and evoked in several international studies. The realization of this right is a responsibility incumbent first and foremost on the States, which are primarily responsible for fulfilling the obligations in this field. Pursuant to article 12 of the International Covenant on Economic, Social and Cultural Rights of 1966 (ICESCR), the States are legally obligated to take necessary steps to prevent and treat their citizens’ illnesses. In fact, since the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) took effect in 1994, analyses have shown that apart from the precariousness of the healthcare systems, the TRIPS patent system prevents least developed countries (LDC) from benefiting from patented medicines and therefore from protecting the public health of their population. The media coverage given to access to HIV-AIDS drugs in South Africa in 1998 revealed to the world the conflict between the protection of pharmaceutical patent rights and the protection of the States’ right to health.

2. The right to health versus pharmaceutical patent rights

The conflict between the two rights has been ongoing since TRIPS took effect in 1994.
In fact, the high prices of certain essential medicines are due to the patent system, which grants it’s holder a monopoly. Nevertheless, an essential medicine must be available and affordable for all populations whatever their origin. However, the exclusive pharmaceutical patent protections system of the TRIPS Agreement prevents other players from producing the same medicine of sufficient quality and in sufficient quantity at an affordable price.
Thus, the World Trade Organization (WTO) recognized the effects of pharmaceutical patents on the price of medicines in the Doha Declaration on the TRIPS Agreement and Public Health of

2001. While recognizing “the right of the Members of the WTO to protect public health and, in particular, to promote access to medicines for all,” the Doha Declaration set forth a certain number of flexibilities allowing Least Developed Countries (LDC) to facilitate access to affordable medicines. The most important flexibility is the extension of the transition period specific to pharmaceutical products.  On November 6, 2015, the TRIPS Council extended this period until January 1, 2033.
Through the extension of the transition period, LDCs, particularly of Sub-Saharan Africa, have the possibility of fulfilling their obligations vis-à-vis their population in accordance with the regional and international agreements on the right to health while at the same time complying with their commitment relating to TRIPS.

3. Implementation of the transition period in Francophone Africa, a question of right to life, to health and to access to scientific development

The NGO Yolse in collaboration with the African Union, the United Nations Development Program (UNDP), UNAIDS, the Ambassador of Senegal, the South Centre and TWN organized a workshop on November 23, 2015 to raise the awareness of the representatives of the OAPI [African Intellectual Property Organization] member States concerning the importance of integrating the flexibility of the transition period in the Bangui Agreement. The Workshop was a success because, thanks to the awareness raising work of the NGO Yolse and its partners, the OAPI member States included the decision of the TRIPS Council of November 6, 2015 exempting LDCs from the obligation to grant or enforce patents on pharmaceutical products and to protect the data resulting from clinical trials in relation with pharmaceutical products until January 1, 2033 in the Bangui Agreement revised in Bamako on December 14, 2015.
The population of Sub-Saharan Africa is the population whose access to essential medicines is the weakest.  According to the World Health Organization, at least one-third of the world’s population does not have access to essential medicines.  This percentage exceeds 50% in the poorest regions of Africa and Asia.
This lack of access to essential medicines in Africa underscores the importance of implementing the TRIPS flexibilities granted to LDCs, particularly the one relating to the exclusion of the patentability of pharmaceutical products and the one concerning clinical trial data.

Since the adoption of the Doha Declaration on Public Health and the TRIPS Agreement in 2001, the LDCs of Sub-Saharan Africa have not been able to exploit the flexibilities made available to them to improve access to medicines. Certain countries have even introduced protective provisions for pharmaceutical patents in their laws that are more restrictive than the TRIPS   Agreement itself.  Through the revised Bangui Agreement of 1999. It is clear that under these circumstances, the States are unable to fulfill their duty to treat and prevent the illnesses of their population pursuant to art.12 ICESCR. However, experience has shown that the absence of a pharmaceutical patents has allowed the development of the pharmaceutical industry of a certain number of developed and developing countries.

For almost 111 years, i.e., from the Paris Convention of 1883 to the effective date of the TRIPS Agreement in 1994, developed countries were able to strengthen their pharmaceutical industries.  It was only after these industries had achieved a sufficient level of development that these countries established – even re-established – the protection of their pharmaceutical manufacturing. By way of example we can cite countries like Germany, France, Japan or Switzerland, which once again protected their pharmaceutical products during the 1960s to the 1970s.  To be fair, it would be desirable for LDCs to have a lengthy period like the developed countries so that they can create infrastructures and benefit from the necessary skills in the fields of research, development and pharmaceutical innovation.

It has often been mentioned that patents are key elements for pharmaceutical innovation and that without them, there would be no more research or development of new medicines.  However, the

current patent system has not fostered research and development in the case of neglected diseases that essentially affect developing countries.  In fact, the production of medicines to fight these diseases has only slight economic appeal for the major pharmaceutical companies. This is why it is necessary to encourage the adoption of the research and development treaty.

4. Proposals for helping to realize the right of the populations of LDCs to life and to health.

Our contribution is the following:

The conversion of the patent department of the national intellectual property offices of least developed countries (LDC) into an innovation, technology and science office (ex.:  Sub-Saharan Africa).

Since LDCs have been released from their obligation to protect pharmaceutical patents and clinical trial data following the extension of the transition period by decision of November 6, 2015, we propose converting the patents departments of the national intellectual property offices of LDCs into an office of innovation, technology and science. Their objective is to ensure national coherence to correct the incoherence at the global level.  They will be in charge of coordinating the following activities:
- The effective implementation of the transition period for LDCs.
- Leveraging flexibilities to foster access to essential medicines.
- Coordinating the different national stakeholders.
- Establishing a strategy for attracting foreign investors.
- Coordinating the national capacity building activities.
- Promoting the adoption of a research and development treaty (R&D).

IMPACT ON POLICY COHERENCE:

The problem of intellectual property and access to medicines, to vaccines and to diagnostic tools is linked to several factors necessitating a coherent national, regional and global approach.  We think that a coherent national policy will have more influence at the global level and therefore on the effectiveness of the entire system. Our proposal deals with national and global coherence.

Frequently in certain LDCs, political instability and constantly changing contacts prevent project monitoring. Additionally, the lack of communication between the different sectors concerned often results in a loss of crucial information. Thanks to coordination work and knowledge of the country’s national realities, the national office of innovation, technology and science that we are proposing would deal with the effective implementation of the flexibilities of the TRIPS Agreement and the special extension of the transition period for LDCs set forth in the Doha Declaration on Public Health and the TRIPS Agreement and the flexibilities of the TRIPS Agreement. Furthermore, it would be responsible for implementing all of the alternative solutions favorable to public health.   Finally, it would ensure that any intellectual property or trade rule that conflicts with access to medicines is revised.


IMPACT ON PUBLIC HEALTH:

At present, we can cite by way of illustration, the Global Fund, the (President's Emergency Plan for AIDS Relief) PEPFAR and other donations that guarantee access to 1st line AIDS drugs.  On the other hand, the case of 2nd and 3rd-line anti-retrovirals (ARV) has not been settled. There are also treatments like those for cancer and hepatitis C that are inaccessible to the populations of LDCs.  For example, the current price of sofosbuvir is 41,000 euros in France and 74,000 euros in the United States for a complete twelve-week treatment. Only competition between generics manufacturers could make these medicines accessible in LDCs.  Today, there are no international funds or donations for these diseases.  Furthermore, these are not sustainable solutions.  Therefore, our proposal would effectively lower the price of and accelerate access to medical products. The budget of LDCs dedicated to purchasing will be the same, but the quantity of medicines available would increase appreciably and they would be available in national pharmacies.  There will also be a general impact on health because the office’s work to promote innovation and research at the national level will make it possible in the long-term to produce medicines locally. If these types of offices exist everywhere in the LDCs of Sub-Saharan Africa, they will be provide human and scientific resources in support of the African Union’s manufacturing plan.


ADVANCING HUMAN RIGHTS:

The coordinated work of the national office would inevitably encourage the progressive and sustainable realization over time of human rights in LDCs. It would thus ensure that the national efforts are dedicated to the achievement of progressive access to pharmaceutical products.  In accomplishing its tasks, the office should strive at both the regional and international levels to prevent all initiatives to strengthen pharmaceutical patent rights relating to LDCs because these rights prevent the States from being able to prevent and treat the diseases from which their populations suffer in accordance with art.12 ICESCR. However, the national office is required to defend the necessity of introducing a treaty governed by international law relating to research and development that disassociates the cost of research and development from the cost of medicines making it possible to undertake research to find medicines intended for neglected diseases. Finally, the office would favor the right of all peoples to acquire knowledge in the medical sciences in order to build a local pharmaceutical production industry, which is essential for achieving the objectives of the right to health. In general, “the right to science is considered a means of advancing toward the realization of other human rights and of responding to the common needs of all mankind. “ In the same way, it has been recognized that the progress of science and of technology and the transfer of science and technology are of major importance for accelerating the economic and social development of developing countries.  This is the condition under which LDCs will be able to achieve the objectives of sustainable development, the right to live and to health.


IMPLEMENTATION:

The conversion of the offices will not require other financial costs because they would operate with the existing budget. The national authorities will potentially be able to strengthen this conversion to expand research and development at the national level in view of local production. What would change would be their objectives, their strategies and the composition of the members. The existing staff would remain in place, but they would be retrained to make their work more relevant with respect to public health needs. The goal is to concentrate the mobilization of national resources, to implement the flexibilities of the TRIPS Agreement and the Doha Declaration on Public Health and TRIPS in order to improve access to pharmaceutical products. This also involves coordinating the national capacity building activities concerning intellectual property and public health, the transfer of technology as well as the creation of capacities in the research and science sectors and a solid pharmaceutical technology. The office is a project targeting the achievement of sustainable development objectives. Therefore, it is presented as a structure that should withstand political instability and the lack of coordination between the different national and international stakeholders. To this end, stakeholders with regard to health, education, scientific research, intellectual property right, industry, trade and foreign affairs should be set up.
A group of experts in promoting access to pharmaceutical products and in pharmaceutical innovation would then provide support for the office.  The office would also work with universities, NGOs and development organizations such as, for example, UNDP, UNCTAD, etc.

In concrete terms, a pilot project could be set up quickly in Burkina Faso. Then, this experience could be extended to other LDCs.

Bibliography and References

Bibliography
1 The Universal Declaration of Human Rights of 1948 (article 25), the International Covenant on Economic, Social and Cultural Rights of 1966 (article 12(1)), the International Convention on the Elimination of All Forms of Racial Discrimination of 1965 article 5 (e) (iv), the Convention on the Elimination of all Forms of Discrimination against Women of 1979 articles 11.1 (f) and 12 and the Convention on the Rights of the Child of 1989 article 24, the WHO Constitution.
2 The European Social Charter of 1961 revised (Art. 11), the African Charter on Human and Peoples’ Rights of 1981 (art. 16) and the Additional Protocol to the American Convention on Human Rights in the area of Economic, Social and Cultural Rights of 1988 (art 10). And the Vienna Declaration and program of action of 1993.
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7 This decisions implements the second and third sentences of section 7 of the Doha Declaration on the TRIPS Agreement and Public Health. Least developed countries will not be required to protect patents for pharmaceutical products or data resulting from clinical trials until January 1, 2016.  Now until 2033.  The LDCs have the right to request a subsequent extension beyond January 1, 2033 (66§1 TRIPS).
8 TRIPS Council decision of November 6, 2015.
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14 Ibid., p.5.
15http://www.lemonde.fr/planete/article/2015/02/10/conflit-autour-d-un-traitement-contre-l-hepatite-c_4573300_3244.html. Consulted on 2/27/2016.
15 ONUSIDA, Using TRIPS flexibilities to improve access to HIV treatment, Policy Brief, 2011, p.5.
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