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Info Service on Health Issues (Nov24/04) Geneva, 25 Nov (K M Gopakumar and Sreenath Namboodiri*) – The Africa Group and Brazil raised concerns about political pressure against the use of patent flexibilities during the 36th Session of the Standing Committee on Patent Laws (SCP) of the World Intellectual Property Organization (WIPO). This took place in a hybrid mode from 14 to 18 October at the WIPO Headquarters in Geneva. The Africa Group and Brazil cited political pressure against the use of flexibilities in the Trade-related Aspects of Intellectual Property Rights Agreement (TRIPS), especially compulsory licenses, during the discussion of the WIPO Secretariat’s report titled “Constraints Faced by Developing Countries and Least Developed Countries (LDCs) in Making Full Use of Patent Flexibilities and Their Impacts on Access to Affordable, Especially Essential Medicines for Public Health Purposes in Those Countries”. This report was discussed under the agenda item 8 on patents and health. The Africa Group stated that “We condemn such unfortunate practices which seek to thwart the use of patent flexibilities, particularly when it comes to use to access of essential medicines for public health purposes. Indeed, the COVID-19 pandemic should be lesson enough that such measures are inevitably counterproductive”. Brazil said that “Developing countries are often subject to external pressures, including political and economic sanctions, when attempting to use flexibilities like compulsory licensing. As mentioned in the document, countries such as Brazil, South Africa, and India have faced challenges from powerful industry actors or trade partners when invoking TRIPS flexibilities. This creates an environment of uncertainty and discourages the full use of these legal tools. These constraints not only delay access to essential medicines but also impact broader public health outcomes by restricting the availability of affordable treatments, particularly for conditions such as HIV/AIDS, tuberculosis, and COVID-19”. Further, Brazil requested the WIPO Secretariat and its Member States to facilitate “international cooperation to mitigate the negative impact of political or economic pressure on countries using compulsory licensing or other flexibilities”. WIPO Report on Constraints in Using the TRIPS Flexibilities The 36th SCP discussed an updated version of the report that had been presented to the 26th Session of SCP held on 3-6 July 2017. The preparation of the updated report (hereafter Report) is mandated by the 35th session of the SCP, held in Geneva in October 2023. The revision is to specifically examine challenges faced by developing countries and LDCs in utilizing patent flexibilities for affordable access to essential medicines. The Report recognises political pressure as one of the constraints to use the flexibilities. It states: “Some publications also cite those cases, most of which are the cases of Brazil, India, South Africa, Thailand and Colombia. At the same time, while noting he concerns about possible negative reactions to grant of compulsory licenses from developed countries’ governments and their implications for trade or political relations, one publication questions the generalisation of the negative effect and the scale of such extrinsic influences”. [When Malaysia issued compulsory licenses for use in government hospitals in 2003 for selected HIV medicines and in 2017 for sofosbuvir to treat hepatitis C, there was also pressure from the companies and their associations, as well as from the US government. The use of this flexibility allowed Malaysia to implement a free national treatment programme for HIV and hepatitis C.] The Report also cites South Africa’s remarks in the TRIPS Council during the discussions on the TRIPS Waiver, noting that TRIPS flexibilities are effectively inaccessible for developing countries due to the risk of sanctions. The report also referenced the pharmaceutical industry’s lobbying efforts, citing Pakistan’s concerns that companies actively push governments to impose sanctions on countries implementing compulsory licensing. The UN Secretary General’s High-Level Panel Report also recognised the role of political pressure in creating a chilling effect on the use of TRIPS flexibilities. It states: “Many governments have not used the flexibilities available under the TRIPS Agreement for various reasons ranging from capacity constraints to undue political and economic pressure from states and corporations, both express and implied. Political and economic pressure placed on governments to forgo the use of TRIPS flexibilities violates the integrity and legitimacy of the system of legal rights and duties created by the TRIPS Agreement, as reaffirmed by the Doha Declaration”. Despite the acknowledgment of political and corporate pressure (from Big Pharma) the WIPO Report neither proposes solutions nor lists specific options for implementing TRIPS and other relevant agreements at national or regional levels. It also does not examine how each option might impact access to affordable medicines. According to the Report, the existence of many bilateral/regional/plurilateral/multilateral agreements makes the implementation of international intellectual property law at the domestic level more complex than in the pre-TRIPS era of the Paris Convention for the Protection of Industrial Property. It states: “… since countries are free to provide more extensive protection than the minimum standards set by the TRIPS Agreement, provided that such protection does not contravene the TRIPS provisions, making a decision to conclude a trade or regional agreement that goes beyond the TRIPS minimum standard could be considered as a mere exercise of their sovereign right to choose an option as they deem fit. On the other hand, as in any negotiation, parties negotiating trade agreements might have asymmetrical negotiation power which may result in, for example, reducing the scope of available flexibilities. During the SCP, one non- governmental organization reiterated its concern on free trade agreements (FTAs), which include obligatory provisions that are not found in the TRIPS Agreement and in its view, are against the public interest”. The Report identified many challenges in the utilisation of TRIPS flexibilities and categorised three primary challenges to implementing flexibilities:
Constraints encountered by governments at the stage of national implementation of flexibilities The Report cites the following constraints faced by governments during the national implementation of flexibilities:
Constructive ambiguity is listed as a constraint because some of the TRIPS provisions remain undefined, leaving room for diverse interpretations, which complicates domestic implementation (but provides policy space if interpreted in accordance with development objectives, public health and other public interests). It states: “…international treaties are often built on so-called “constructive ambiguity” terms and provisions that may, in the eyes of the negotiators, lend themselves to different interpretations, with effect, in turn, on the perceived scope of available flexibilities.” As a result, irrespective of the clear policy option to promote access to medicine the Doha Declaration on the TRIPS Agreement and Public Health when it comes to the implementation of “the ways in which texts of international treaties are drafted, and the possibility of interpreting them in more than one way, often lead to different understandings about the full range of options available for their implementation”. Regarding the complexity of practical information, the report mainly discusses the constraints of the implementation of Article 31bis of TRIPS (related to production for export involving compulsory licensing) and lists the following constraints cited in an ARTNeT Working Paper Series, No.225: 1. Constraints specifically embedded within the system itself: examples commonly cited include the need for prior notification and the requirement for special labelling. 2. Constraints resulting from specific choices made at the domestic level in implementing the system, which are more restrictive than is required under TRIPS: a commonly cited example is a requirement for eligible medicines to be specifically scheduled under domestic legislation before an application for a license can be made. 3. Constraints that are inherent in the use of compulsory licensing more generally: examples include the need for specific authorisation for use, as opposed to an entitlement to produce generic medicines without government authorization […]. 4. Constraints that are not directly related to the IP system or patent rights as such, but rather relate to other aspects of production and supply: these include regulatory approval in either exporting or importing countries or both, the viability of production of small runs of medicines, and procurement policies and procedures. (ARTNet is the Asia-Pacific Research and Training Network on Trade.) Complex administrative processes, including the lack of clarity on the scope of flexibilities and the involvement of the role of multiple administrative bodies, are also cited as a constraint. Further, the Report cites the following statement of Nigeria on behalf of the Africa Group to illustrate the lack of institutional capacity in using TRIPS flexibilities: “… the majority of developing countries did not have the technical capacity to make use of those flexibilities, for example, compulsory licensing”. […] the lack of capacity to fully comprehend the full range of the flexibilities that could be implemented raised concerns about costly violations of existing agreements”. Constraints faced by various stakeholders in using a national legal framework that has implemented policy options
Procedural complexities also restrict the use of flexibilities. Stakeholders encounter burdensome administrative processes, unclear licensing conditions, and a lack of procedural clarity within national frameworks. The Report argued that effective implementation of these flexibilities requires streamlined, accessible procedures, but many developing countries lack the necessary legal and technical expertise. For example, the lack of relevant information to identify the relevant patents and their status affects the ability of generic companies to make effective use of flexibilities. Similarly, it notes the importance of trained human resources in using the flexibilities and highlights “… the so-called patent agents or patent attorneys, [who can be consulted] on the use of exceptions and limitations” for “challenging the validity of patents or obtaining patent protection on local improvement made on existing medicines, among others. Their expertise in searching patent documents, analyzing patent claims and providing legal advice may be also relevant for the local business to make use of the patent system for their benefit”. Further challenges arise from inconsistencies between patent and drug regulatory laws. Even when parallel importation is permitted, a lack of alignment with regulatory agencies hinders the effective use of flexibilities. Other challenges where use of patent flexibilities alone may not achieve intended policy outcomes
The Report also highlights the limited manufacturing and financial capacity of many developing countries, which remain heavily reliant on imports for medical needs. However, generic manufacturers also need to carry out certain studies to obtain marketing approval. Moreover, stringent international quality standards constrain production (those often influenced by Big Pharma but with no significant value added to safety, efficacy and quality), while newer technologies like mRNA vaccines involve complex production processes and scarce raw materials. Accessing patent information is another issue, as varying formats and sometimes language across jurisdictions complicate data accessibility, which impedes informed decision-making about flexibilities. The Report concluded that multiple factors, from legal complexities to practical implementation barriers, restrict the effectiveness of patent flexibilities. Addressing these constraints requires tackling both legal and operational hurdles while improving coordination among stakeholders and regulatory bodies. It noted that the low global incidence of compulsory licensing may not necessarily reflect constraints but could be due to factors such as the absence of relevant patents or alternative solutions achieving similar outcomes. However, the fact is that the Report has identified political and corporate pressure constraining use of TRIPS flexibilities. (*Sreenath Namboodiri is pursuing an LLM in International Law at the Geneva Graduate School.)
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