Submission: South Centre
Country: Switzerland

Abstract

This submission by the South Centre responds to the call by the UN High Level Panel on Access to Medicines for contributions to address the policy incoherence between the rights of inventors, international human rights law, trade rules and public health where it impedes the innovation of and access to health technologies.

In our view, an effective way to address policy incoherence in these areas is first and foremost, to assert the primacy of the right to health for all, over trade and intellectual property rules. The attainment of good health and well-being is an objective as well as a human right, whereas trade or intellectual property is a means; thus there should be primacy of health over trade or IP.

Submission

In our view, an effective way to address policy incoherence in these areas is first and foremost, to assert the primacy of the right to health for all, over trade and intellectual property rules. The attainment of good health and well-being is an objective as well as a human right, whereas trade or intellectual property is a means; thus there should be primacy of health over trade or IP.
In this context, the following recommendations are made:

Recommendations
- Developing countries should tailor their intellectual property regimes to their own domestic technical, economic and social needs and capacities. To this aim, these countries should incorporate the TRIPS flexibilities into national patent law to enhance access to medical products (Correa 2010). The implementation of these flexibilities is a means to balance patent rights with the right to health; stimulate competition; protect consumers; and facilitate access to generic medical products that are accessible and affordable to governments and consumers.

A key flexibility is that countries are free to determine in their own way the definition of an invention, the criteria for judging patentability and patentable subject matter, the rights conferred on patent owners and what exceptions to patentability are permitted, subject to meeting the minimum standards laid down in the WTO TRIPS Agreement. Countries should apply a rigorous definition of patentability criteria. Moreover, revision of national patent laws to allow and effectively use of other flexibilities should be promoted. These include: compulsory licenses and government use authorization, parallel importation, research exception, limit the extent of test data protection, and develop a robust patent examination systems with pre-grant and post-grant opposition.

- Patent offices should be encouraged to reject pharmaceutical patent applications as not constituting inventions for the following: new dosage forms of known medicines, new salts, ethers, esters and other forms of existing pharmaceutical products, discovery of polymorphs of existing compounds, enantiomers, therapeutic, diagnostic or surgical methods of treatment and claims for new uses of known products.

- Countries should take measures to control anti-competitive practices and abuse of intellectual property rights in their jurisdictions. Multilateral trade rules allow substantial flexibility in the development and application of competition law and policy. As a consequence of accommodating the variety of potential competition approaches, remedies available to address anti-competitive behaviour may permit a broader range of remedial action than some other public health-related flexibilities associated solely with patents (UNDP, 2004).
- Developed countries should stop the use of unilateral trade measures and free trade and investment agreements as a means to pressure countries to undertake TRIPS plus commitments. The recent rise of bilateral and multilateral FTAs threatens public health and access to affordable medicines. Strong trade and power asymmetries exist between developed and developing countries during FTA negotiations. Trade-oriented pressures are applied to developing countries to surpass the protection afforded by TRIPS and to diminish the system of the TRIPS flexibilities. These are ill-suited ‘TRIPS-plus’ solutions (Smith, 2007).
Furthermore, the special rapporteur (Grover, 2009) on the right to health pointed out that: “TRIPS-plus provisions in FTAs differ from agreement to agreement, but their purposes are by and large to: Extend the patent term, introduce data exclusivity, introduce patent linkage with drug registration and approval, and create new enforcement mechanisms for IPRs.
- There should be the promotion of reform of African regional IP organizations – ARIPO and OAPI – in order that they accommodate to the flexibilities available under TRIPS such as the transition period for LDCs as well as application of strict criteria of patentability. The current operations of ARIPO do not facilitate the full use of TRIPS flexibilities and instead erects patent barriers to the importation and local production of affordable medicines (South Centre, 2014).
- LDCs should make (and should be provided assistance to do so) effective use of the current transition period that allows them to not apply pharmaceutical patent protection, test data protection or exclusive marketing rights; and recommend that the current waiver be made permanent until the time an LDC graduates from that status. At present, LDCs are not be obliged to implement or apply or to enforce patents as well as test data protection for pharmaceutical products, or to make available a mechanism for filing patent applications for pharmaceutical products (mailbox) or to grant exclusive marketing rights to such applications, until 1 January 2033 or the expiry of such later transition period that may be granted by the WTO Council for TRIPS. LDCs should actively use the created policy space in this transition period and take immediate steps to amend their respective national laws to provide for such exclusions.

- There should be a ban on the application of non-violation and situation complaints with respect to the TRIPS Agreement. Introduction of non-violation complaints under TRIPS could enable legal challenges to regulatory and public policy measures that may be consistent with the obligations under the TRIPS Agreement. For example, public health measures such as issuance of compulsory licenses, or packaging restrictions on harmful products could be challenged even if these are consistent with TRIPS obligations if non-violation complaints are allowed. Unlike non-violation complaints in GATT, where a finding of nullification or impairment of the expected benefits would lead to an adjustment of the impugned tariff measure, in TRIPS this would lead to an amendment of the substantive obligations under the agreement. In this way, it can undermine the balance of rights and obligations and interests of right holders and users in TRIPS. Moreover, non-violation complaints could lead to narrowing the scope of flexibilities under the TRIPS Agreement. The experience of non-violation complaints under GATT suggests that the existence of non-violation complaints has led the panels to adopt a narrow interpretation of the provisions of GATT. For example, while TRIPS requires the grant of patents in all fields of technology if the patentability criteria are satisfied; it does not define novelty, inventive step or industrial applicability. This allows for diversity in the treatment of patent applications in different territories which enables developing countries to define what is patentable very narrowly. If non-violation complaints were allowed, it is possible that decisions to reject a patent based on a strict definition of the patentability criteria may be challenged. Therefore, non-violation complaints would seriously impair the balance of rights and obligations enshrined under TRIPS.

- WIPO and other international organizations should provide technical assistance on IP policy to developing countries that builds their capacity on the use of TRIPS flexibilities.
- WIPO and WTO should undertake human rights impact assessments prior to any norm-setting activities, especially if they have an impact on public health.
- The results of publicly funded research should be made available to all, and not be eligible for patent protection. Global, open access to publicly funded research should be promoted to advance collaborative scientific research and avoid unnecessary and costly duplication of work.
- There should be greater transparency by pharmaceutical firms, product development partnerships, biotechnology firms and other entities, in disclosing the real costs of research and development, including in carrying out clinical trials, and for them to share the results of clinical trials.
- New initiatives and business models to stimulate R&D in medical products that “de-link” the cost of R&D from prices should be promoted. However, principles need to be established to ensure that if public resources are used to promote de-linkage, there is full transparency on the real costs of activities; disclosure of terms in contractual agreements for R&D and for IP; and that priorities for R&D are defined in accordance to public health needs.

References and Bibliography

Correa C.M. (ed.) (2012). A Guide to Pharmaceutical Patents, South Centre, Geneva. Correa, C.M. (2010).

Designing Intellectual Property Policies in Developing Countries. Third World Network. Correa, C.M. (2000).

Integrating Public Health Concerns into Patent Legislation in Developing Countries, South Centre, Geneva. Grover, Anand (2009).

“Report of the Special Rapporteur on the Right of Everyone to the Enjoyment of the Highest Attainable Standard of Physical and Mental Health.” Matthews, D.N. (2014).

When Framing Meets Law: Using Human Rights as a Practical Instrument to Facilitate Access to Medicines in Developing Countries. TRIPS and Developing Countries: Towards a New IP World Order? Edward Elgar, Cheltenham, UK. Reid Smith, Sanya (2007).

Intellectual Property in Free Trade Agreements. Penang, Malaysia: Third World Network. Reid Smith, Sanya (2015).

“Potential Human Rights Impacts of the TPP”, available from http://www.twn.my/title2/FTAs/General/TPPHumanRights.pdf. South Centre (2014).

The African Regional Intellectual Property Organization Protocol on Patents: Implications for Access to Medicines. Research Paper 56, South Centre, Geneva. UNDP (2004). (ed. F.M. Abbott.

Using Competition Law to Promote Access to Health Technologies: A Guidebook for Low- and Middle-Income Countries.