Trips And Right To Health In The Time Of Covid-19

Apr 15, 2020


During these challenging times while every single country is struggling to fight against a single cause, COVID-19 (coronavirus), jurists and lawyers are discussing the inevitable impacts of this pandemic. Across the globe, people are anticipating a miraculous vaccine or medication to end this ambiguous wait. Moreover, the invention possibility of a vaccine or a medication brings the question of patentability into mind. A patent right might be limiting the usage of this potential cure and defining its beneficiaries. This article endeavors to point out briefly the general overview on what we can expect from multilateral legal system in terms of intellectual property rights (“IPR”) and right to health as competing rights in case a “cure” to coronavirus is to be invented.  

As a strong incentive for innovation, investment and trade, intellectual property protection has been regulated multilaterally through Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS”) as the Annex 1C of the Marrakesh Agreement Establishing the World Trade Organization (“WTO”) that entered into force on 1 January 1995. The TRIPS is an integral part of the WTO Agreement and a binding text for each Member State from the date the WTO Agreement becomes effective for that country[1]. TRIPS regulate the minimum standards of IP protection, which opens a path to Member States for TRIPS-plus implementations to be regulated within their domestic law. While the TRIPS deals with each categories of intellectual property rights, the text sets out standards of protection, rules on administration and enforcement of IPR, and also provides WTO dispute settlement mechanism in resolving IP related disputes between Member States.

Within the scope of this article mentioned above, the objectives and principles within the TRIPS will be studied briefly. The objectives of the TRIPS which also reflect the concerns of the negotiator States, have been identified not only within the provisions of the Agreement but also in the Preamble as follows:

“to reduce distortions and impediments to international trade, and taking into account the need to promote effective and adequate protection of intellectual property rights, and to ensure that measures and procedures to enforce intellectual property rights do not themselves become barriers to legitimate trade;”

While the Preamble reflects the pro-trade concerns, the Articles 7 and 8 of the TRIPS[2] exist to balance the ones that may be classified as pro-humanitarian. The objective of establishing a balance between the competing goals of IPR owners and public interest is ensured through the wording and interpretation of the Dispute Settlement Bodies of WTO through its jurisprudence. Paragraph 1 of Article 8 recognizes the right of the Member State to adopt necessary measures to protect public health and nutrition and also to promote the national public interest along with Article 7 to be taken into account. Hence the issue which concentrates on whether the public interest may overrides trade related IPR or not, has been clarified in Canada – Pharmaceuticals Patents case. The case is regarding Canada’s practices to allow production of generic medicines before the expiry term of the patent. While Canada had accepted the fact that the practices were in violation of the provisions conferring patent rights stipulated in the Article 28 of the TRIPS, they also argued that the practices were justified under the Article 30 stipulating exceptions along with Articles 7 and 8 dealing with objectives and principles of the text. The governing jurisdiction of WTO emphasized that the application scope of the Article 30, which regulates the exceptions, should be determined with particular care on the goals and the limitations stated in the Articles 7 and 8.1. The governing jurisdiction also stated that not only the exception provisions, but also other provisions of the TRIPS shall be read together with the Articles 7 and 8.1[3], which has become another signal for the Member States whereas the flexibilities issue arises. Thus, it has been recognized for the realization of the stated right that the TRIPS “can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all”.

In this context, the fact that WTO Members should not only be required to pursue trade related multilateral obligations but also other relevant legal texts should be acknowledged. The Article 25 of the Universal Declaration of Human Rights provides that a standard of living adequate for the health and well-being of the individual and his/her family including medical care is a fundamental right to which all human beings are entitled[4]. Furthermore, the Article 12 of the International Covenant on Economic, Social and Cultural Rights obliges States to take the necessary steps to realize the enjoyment of the highest attainable standard of physical and mental health, including: the prevention, treatment and control of epidemic, endemic, occupational and other diseases; and the creation of conditions which would assure to all medical service and medical attention to all in the event of sickness[5].

As to be discussed below, this article will point out possible incoherencies between the right to health, trade, intellectual property rights and public health objectives. Although the current situation on coronavirus is yet to be seen, the author finds it useful to discuss the possible outcomes.

As explained above, while the TRIPS canalized trade law to a new era of obligations as regards the IP protection and enforcement, it has also ensured in theory a room for maneuver for WTO Members through flexibilities in order to fulfill human rights and/or public health objectives. It is crucial to state that not all TRIPS flexibilities have been structured to fulfill stated public policies. Human rights law recognizes that the full achievement of all rights requires resources[6] and it is unlikely to expect full commitment to TRIPS obligations from a resource-constrained country. Consequently, the author is anticipating that developing countries and least developed countries (“LDCs”) who are dependent to export products in terms of medical supplies will be suffering in the forthcoming weeks or months with the intent of striving the virus.

In this context flexibilities in general ensured by the TRIPS[7] will be briefly mentioned as a possible tool to fight against coronavirus should the scientists achieve to come up with a lifesaving yet patented cure:

  1. Article 6, Parallel Import (Exhaustion): The TRIPS does not mandate a particular approach to the exhaustion of IPRs which is highly significant since the international exhaustion makes it possible to allow the parallel import of the products without the consent of the IPR holder, if that product was put on the market of the exporting country by or with the consent of the right holder[8].
  2. Article 27, Patentability Criteria: WTO Members may freely adopt their own definitions of novelty, inventive step and industrial application[9]. Members can also refuse to grant patents for certain subject matters through this flexibility.
  3. Article 30, General Exceptions: WTO Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner[10].
  4. Article 31, Compulsory Licensing: A non-voluntary license may be granted by a duly authorized administrative, quasi-judicial or judicial body to a third party to use a patented invention without the consent of the patent holder, subject to the payment of adequate remuneration in the circumstances of each case.
  5. Article 31, Government Use: A government authority may use a patent without the consent of the patent holder for public, non-commercial purposes, subject to the payment of adequate remuneration in the circumstances of each case.
  6. Article 8 & 31(k) & 40, Competition-related Provisions: Members may adopt appropriate measures to prevent or remedy anti-competitive practices relating to intellectual property. These include compulsory licenses issued on the basis of anti-competitive conduct and control of anti-competitive licensing.
  7. Article 65 & 66, Transition Periods: LDCs are not required to provide patent or data protection in general until 1 July 2021 and on pharmaceutical products are not required to grant or enforce patents or data protection until 1 January 2033, or a subsequent date as agreed by WTO Members[11].

In light of the stated flexibilities, which may be used both as a path to TRIPS-plus provisions or an instrument to fulfill required public policies of the Member State such as fight against coronavirus and its compelling impacts. At this point, by remembering the HIV/AIDS epidemic during the 2000s[12], the author hopes the World not to experience the failure of the compulsory license mechanism once again. To briefly explain; compulsory licensing is regulated under Article 31 (f) of the TRIPS stipulating that a compulsory license must be issued predominantly for the supply of the domestic market of the Member State granting the license. Although this mechanism was set out primarily in good faith and hopeful ambitions, negotiator States themselves have neglected that many Member States did not have sufficient or adequate pharmaceutical production capacity in terms of pharmaceutical sector and due to the fact that pharmaceutical business requires a high level of investment compared to other trade sectors. Without the significant sector, the Member States could and cannot rejoice the advantage of the compulsory licensing provisions of TRIPS.

In conclusion; considering the scope of the measures that need to be taken by the States in response to coronavirus; a potential cure, in the form of either vaccine or medication may arise patent protection issues. At this stage, multilateral legal system would be referring to flexibilities provided by TRIPS while taking into account the IPR owners privileges and public interests such as the public health.

Att.Meltem Manav

[2] The Article 7 of the TRIPS: “The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.”

The Article 8.1 of the TRIPS: “Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development, provided that such measures are consistent with the provisions of this Agreement.”

[3] In Canada – Pharmaceutical Patents (2000), para. 7.26.

[4] Article 25(1) of the Universal Declaration of Human Rights of 1948.

[5] Article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) of 1966. (

[6] Article 2 of the ICESCR.

[7] UNAIDS, TRIPS Flexibilities and Access to Antiretroviral Therapy: Lessons from the Past, Opportunities for the Future, 2011. (

[8] Peter Van den Bossche & Werner Zdouc, The Law and Policy of the World Trade Organization, third edition, 2014, p: 971.

[9] The French patent law provides an interesting example of a patent law that differentiates the treatment of pharmaceutical products on public health grounds. It provides that: “Where the interest of public health demand, patents granted for medicines or for processes for obtaining medicines, for products necessary in obtaining such medicines or for processes for manufacturing such products may be subject to ex officio licenses in accordance with Article L. 613-16 in the event of such medicines being made available to the public in insufficient quantity or quality or at (abnormally high prices) by order of the Minister responsible for industrial property at the request of the Minister responsible for health.”

[10] In Canada – Pharmaceutical Patents (2000), para. 7.73, the Panel states: “To make sure of the term “legitimate interests” in this context, that term must be defined in the way that it is often used in legal discourse – as a normative claim for protection of interests that are “justifiable” in the sense that they are supported by relevant public policies or other social norms.”

[11] WTO: 2015 News Items, WTO members agree to extend drug patent exemption for poorest members. (

[12] This paper will not be examining the details of the HIV/AIDS pandemic. However the developing countries and LDCs could not benefit from the compulsory licensing scheme due to technical and administrative complexity of the relevant system.