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Info Service on Health Issues (Aug24/01) New Delhi, 7 August (K M Gopakumar and Chetali Rao) – The draft UN General Assembly (UNGA) Political Declaration on Antimicrobial Resistance that is under negotiations is silent on the use of TRIPS flexibilities, thus indirectly legitimizing further entrenchment of the current inequitable intellectual property (IP) regime. (TRIPS is the Trade-related Aspects of Intellectual Property Rights Agreement administered by the World Trade Organization.) The Political Declaration is expected to be adopted at the High-Level Meeting on Antimicrobial Resistance (AMR) on 26 September 2024 during the 79th UNGA Session. Informal consultations have been taking place since May 2024 with Vanessa Frazier and Francois Jackman, respectively Permanent Representatives of Malta and Barbados to the United Nations, as co-facilitators. The Political Declaration is structured as follows: Preamble; Part I: Governance; Part II: Financing; Part III: Access; Part IV: Coordinated Multisectoral Approach; Part V: Research and Development, Training, Innovation and Manufacturing; Part VI: Surveillance and Monitoring; Part VII: Follow Up. Each Part consists of recitals and commitments. The second revised version of the draft Political Declaration dated 17th July (Rev2) is silent on TRIPS flexibilities. The use of TRIPS flexibilities has the potential to facilitate access to a new generation of antibiotics and other anti-microbial health products, which are under product patent protection. TRIPS flexibilities allow countries to issue compulsory licenses to facilitate import or manufacturing of affordable generic versions of patented antibiotics and antimicrobial agents, which would often be under patent protection. Similarly, TRIPS flexibilities also allow countries to deny patents on the new use or new dosage of old antibiotics and antimicrobial agents. The lack of explicit reaffirmation of TRIPS flexibilities is thus a concern. Furthermore, Paragraph 93 that deals with research and development, training, innovation and manufacturing in Part V of the Political Declaration indirectly endorses the current IP regime as the dominant approach with multinational corporations (MNC) continuing to hold centre stage. It states: “Recognize the important role played by the private sector in research and development of innovative medicines and continue to support voluntary initiatives and incentive mechanisms that separate the cost of investment in research and development from the price and volume of sales, facilitate equitable and affordable access to new tools and other results to be gained through research and development”. This Paragraph recognises the role of the private sector in research and development (R&D) as central and continues to support merely MNC goodwill and voluntary efforts to promote equitable and affordable access. This could be interpreted as an indirect legitimisation of IP norms and practices that are barriers to access and putting a question mark on the use of compulsory or government-use licenses to facilitate affordable access. The lack of direct reference to IP barriers and challenges to affordable access in the AMR context is not new. The first Political Declaration on AMR in 2016 was also silent on the use of TRIPS flexibilities but Paragraph 10(d) of that Declaration states: “Underline further that affordability and access to existing and new antimicrobial medicines, vaccines and diagnostics should be a global priority and should take into account the needs of all countries, in line with the World Health Organization global strategy and plan of action on public health, innovation and intellectual property [GSPOA], and taking into consideration its internationally agreed follow-up processes”. (WHO’s GSPOA is explicit and detailed on the use of TRIPS flexibilities.) While Rev2 in 2024 contains similar references, the difference is that Paragraph 83 of Rev2 is not under the access sub-heading but in the one dealing with research and development, training, innovation and manufacturing. Paragraph 83 of Rev2 states: “Recognize that access that affordability and access to existing and new antimicrobial medicines, vaccines and diagnostics should be a global priority which takes into account the needs of all countries, in line with WHO’s global strategy and plan of action on public health, innovation and intellectual property, and note that addressing the numerous causes for lack of access to effective antibiotics, …” It is further weakened by being only a recital and not a commitment. Paragraph 96 of Rev2 is worrisome because it contains an IP enforcement agenda. It states: “Undertake and enhance targeted measures, including activities identified by the WHO Member State Mechanism on Substandard and Falsified Medicines, to address the trade in sub-standard, counterfeit and falsified medicines, through, inter alia, improving supply chain management and strengthening regulatory and surveillance capacity”. The word “counterfeit” is used for a particular type of trademark infringement which is in the realm of IP. The TRIPS Agreement defines a counterfeit trademark as follows: “Counterfeit trademark goods” shall mean any goods, including packaging, bearing without authorization a trademark which is identical to the trademark validly registered in respect of such goods, or which cannot be distinguished in its essential aspects from such a trademark, and which thereby infringes the rights of the owner of the trademark in question under the law of the country of importation.” According to the TRIPS Agreement, WTO Member States are under an obligation to provide criminal procedures and penalties for wilful trademark counterfeiting. Further, border measures are also applicable to the import of goods having counterfeit trademarks. In contrast, the role of the WHO Member State Mechanism on Substandard and Falsified Medicines is to safeguard access to safe and effective medicines, vaccines and other medical products. To conflate this with trademark infringement as is contained in Rev2 means that enforcement of safety and quality medicines is mixed up with IP enforcement which is not within the competence of health-related authorities. [30 years of the wrong use of the word “counterfeit” at the WHO when referring to quality-compromised medicines, was finally ended following years of intense discussion when the World Health Assembly officially dropped the use of the word in 2017. See: Member State Mechanism agrees to drop “counterfeit” term.] Access Part III of the Political Declaration deals with access. Though Paragraph 40 recognises the “equitable and timely access to effective antimicrobials, diagnostics and vaccines for human and animal health remains a challenge for developing countries,” it does not recognise the special problems of access to newly developed antimicrobials in developing countries. It acknowledges that “access to existing and newly developed antimicrobials and complementary diagnostics remains a challenge within and among countries”. Similarly, Paragraph 41 expresses concern about the concentration of manufacturing facilities in a few countries and the lack of national production capacities but fails to address the issue in the commitments section. A broad reference is made in Part V on R&D (Paragraph 91) that relies on the goodwill of the private sector: see below. Paragraph 42 “Notes that the high prices and out-of-pocket expenditures for some health products and services, including antimicrobials, and inequitable access to such products and services within and among countries, as well as financial hardships associated therewith, continue to impede progress towards mitigating the effects of antimicrobial resistance”. However, there are again no concrete solutions in the commitment part. The commitment to facilitate access is limited to mainly two points: First, acceleration of the efforts to have universal health coverage (UHC). Second, efforts to promote access to antimicrobials in the WHO Model List of Essential Medicines. Paragraph 45 states: “Promote greater and equitable access and supply of antimicrobials, vaccines and diagnostics in developing countries, especially in low- and middle-income countries, in line with global lists of essential medicines, including WHO Model List of Essential Medicines and the Global Essential Veterinary Medicines List, taking into account national contexts and to update country-aligned lists and treatment needs”. Paragraph 45 also proposes the encouragement of Quadripartite organizations “to coordinate efforts and take actionable steps to support global and regional access initiatives, to ensure effective infectious disease management including enhancing timely and equitable access to and affordability of quality antimicrobials, diagnostics, vaccines, and alternatives to the use of antimicrobials”. The commitments in the R&D part (Part V) are vague in promoting affordable access. It vaguely refers to providing incentives including push and pull mechanisms to develop new health products and technologies while “ensuring that mechanisms are in place for equitable access, particularly in developing countries” (Para 90). Paragraph 92 refers to improving access and affordability by “increasing transparency of prices of medicines, vaccines, medical devices, diagnostics, assistive products, cell- and gene-based therapies and other health technologies across the value chain”. Paragraph 91 is highly inadequate, stating as follows: “Promote the transfer of technology and know-how and encourage research, innovation and commitments to voluntary licensing, where possible, in agreements where public funding has been invested in the research and development of antimicrobials, to strengthen local and regional capacities for the manufacturing, regulation and procurement of needed tools for equitable and effective access to vaccines, therapeutics, diagnostics and essential supplies, as well as for clinical trials, and to increase global supply through facilitating transfer of technology within the framework of relevant multilateral agreements”. Thus, it ignores the growing call, especially in the light of gross inequitable access to COVID-19 medical products, for compulsory technology transfer of publicly funded health products and technologies. Entrenching Commercial Interests The Political Declaration Rev2 is conspicuous in its silence on placing any regulation on the pharmaceutical industry on the marketing of antimicrobials, especially antibiotics. The unethical marketing of health products is one of the contributory factors of AMR. While Paragraph 53 acknowledges the various drivers of AMR, there is nothing on the role of lax or no regulation of the marketing of antimicrobials. WHO’s Global Strategy for Containment of Antimicrobial Resistance in 2001 states: “Promotion of products to health professionals informs prescribers about the range of drugs available and alerts them to the availability of new agents. Inherently, pharmaceutical marketing results in the highlighting of potential benefits and advantages of new agents over existing agents to the extent allowable. Under these circumstances it is often difficult for prescribers to identify the most appropriate role of the new agents within the context of existing protocols. Promotional materials often emphasize simple messages in preference to more complex ones, not infrequently resulting in over-prescribing”. It further states: “The desire to profit from making the sale and/or to favor a particular company’s product in expectation of rewards may override clinical judgement. In this manner, the decision regarding the necessity for treatment and the choice of the most suitable agent are less likely to reflect appropriate clinical management”. The Global Action Plan on Antimicrobial Resistance 2016 also identifies regulation and control of promotional practices by the industry as an action of Member States under objective 4 i.e. Optimize the use of antimicrobial medicines in human and animal health. Apart from the silence on regulation, Rev2 is also silent on the regulation of the use of antibiotics in agro-food industries such as the use of antibiotics for growth promotional purposes. The only reference is Paragraph 73 with a very broad commitment to phase out the use of antimicrobials for growth promotion. It states: “Ensure by 2030 that the use of antimicrobials in animals and agriculture is prudent and responsible and continue phasing out the use of antimicrobials for growth promotion starting with those which are medically important for human health”. An opinion published by the European Public Health Alliance reveals that “A staggering 70% of antibiotics sold globally are used in food production. Growth promotion and routine antibiotic use are the main sources of antibiotic misuse and overuse, as explained in the next sections. Increasing animal welfare standards together with other specific measures such as increasing biosecurity in farms and improving vaccination can significantly reduce this number. In the EU between 2011 and 2022 the overall sales of antimicrobials for animals fell by 53% between 2011 and 2022 following the implementation of stricter regulations on antibiotic use in agri-food systems”. There are paragraphs promoting trade and thus helping the industry using health concerns. For instance, as mentioned above Part III dealing with access does not offer any concrete solutions to address equitable access but focuses on strengthening the supply chain. Paragraph 47 calls on “the Quadripartite to work with World Customs Organization on helping countries to strengthen regulation and control of antimicrobials in the supply chain at national and regional level”. This seems to be more of pushing a trade agenda in the name of access. (The Quadripartite of the Food and Agriculture Organization, the UN Environment Programme WHO and World Organization for Animal Health was convened to coordinate on implementing the Global Strategy on AMR.) In the same way Paragraph 85 recites: “Acknowledge the need to remove trade barriers that are inconsistent with World Trade Organization agreements, strengthen supply chains, facilitate the movement of medical and public health goods, and diversify manufacturing capacities across regions, especially during pandemics and other health emergencies among and within countries”. Read as a whole, the Political Declaration Rev2 pushes the dominant role of the multinational private sector within a supply chain strengthening agenda, and reinforces the current inequitable IP regime, all of which could lead to further concentration of production and perpetuation of lack of timely and affordable access to AMR products. (With inputs from Chee Yoke Ling.)
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