I WTO nå foregår det samtaler på et høy politisk nivå mellom USA, EU, India og Sør-Afrika om TRIPS waiver forslaget. Samtalene fasiliteres av generaldirektøren i WTO.
Det internasjonale sivilsamfunnet har derfor skrevet et brev til genereldirektøren i WTO for å trekke frem noen viktige punkter:
- En TRIPS waiver må som et minimum omfatte vaksiner, medisin og tester for COVID-19
- EU sin posisjon om å endre litt på reglene på tvangslisenser i artikkel 31bis vil ha veldig liten effekt og er derfor ikke et akseptabelt alternativ.
- Et resutat av TRIPS waiver samtalene må være at potensielle produsenter får full frihet til å operere (produksjon, import og eksport), og at det ikke er tyngende betingelser knytta til bruken av et TRIPS unntak.
- Lengden på et TRIPS unntak må også være tilstrekkelig.
Civil Society Letter to the World Trade Organization
Dr. Ngozi Okonjo-Iweala
Director General
World Trade Organization
Ms Anabel González
Deputy Director General
World Trade Orgnization
Dear Dr. Ngozi and Ms. González,
COVID-19 has disrupted societies, wreaked economic havoc, and affected livelihoods, with developing and least developed countries disproportionately impacted. UNCTAD has highlighted that the damage from the COVID-19 crisis has exceeded that of the Global Financial Crisis in most parts of the global economy, but has been particularly draining on the developing world. The crisis has been exacerbated as promises of solidarity and collaboration towards equitable access have mostly failed to materialise.
We join co-sponsors of the TRIPS Waiver proposal and other developing countries in stressing that for a credible WTO response to the pandemic, it must deliver a bold and meaningful outcome on the TRIPS waiver proposal and address concerns about the impact of intellectual property on timely and affordable access to medical products. In this letter, we would like to highlight some key aspects that should guide consultations and negotiations on this matter to deliver a meaningful outcome.
The main purpose of the waiver proposal is the prevention, treatment and containment of COVID-19 and expanded and diversified supply, lower affordable prices, and more equitable access of the full range of medical products are needed towards this end. Of particular importance are diagnostics, therapeutics and vaccines. Some WTO Members have supported an IP waiver, albeit only for vaccines. However domestically, these same Members have emphasized the significance of testing and treatment in controlling COVID-19 infections. Dr. Anthony Fauci, chief medical adviser to the President and NIAID Director has stated that “New antivirals that prevent serious COVID-19 illness and death, especially oral drugs that could be taken at home early in the course of disease, would be powerful tools for battling the pandemic and saving lives,” while Dr. David Kessler, Chief Science Officer for the Biden Administration’s COVID-19 Response said “An easily administered oral antiviral drug would be an important part of our therapeutic arsenal that would complement the great success of our vaccine efforts”.[1] Testing and access to diagnostics, especially antigen rapid diagnostics is essential to peoples’ knowledge of their health status, compliance with public health measures, connection to treatment and care, and pandemic surveillance.
The EU COVID-19 therapeutic strategy also states “vaccines will not eliminate the disease overnight and therapeutics will still be needed for patients in hospitals and at home, including people suffering from ‘long COVID’ (the long-term effects of COVID-19 infection). For these reasons, therapeutics will continue to play a significant role in the response to COVID-19, complementing the successful EU strategy for COVID-19 vaccines.”[2] Notably WHO's COVID-19 Strategic Preparedness and Response Plan has underlined the importance of diagnostics, therapeutics and vaccines for an effective COVID-19 response.[3] For this reason, any credible waiver outcome must also equally cover the medical products essential to control COVID-19 and especially vaccines, therapeutics and diagnostics, including their materials and components. Addressing access to therapeutics and diagnostics must not be delayed.
It has previously been reported that some Members such as the EU wish to limit the waiver to the notion of compulsory licensing of patents only especially in the context of Article 31bis mechanism (CL for exports).[4] In addition, reportedly, some Members, the EU in particular are unwilling to consider unconditional waivers of other provisions such as Article 31(f), Article 28.1, Article 39, and Part III of TRIPS (enforcement requirements). This position of the EU and others is absolutely unjustified and should not be accepted.
We recall that even prior to the pandemic, the challenges of using compulsory licensing mechanism for exports (Articles 31(f) and Article 31bis) and its ineffectiveness to deliver equitable access were well-known.[5] In addition, these CL provisions are only relevant to patents and do nothing to address other intellectual property barriers. For example, information related to manufacturing and quality control processes are often claimed by industry as trade secrets, even when this information bears clear public interests to boost the diversification and scale of production. As such, a waiver of Article 39 of TRIPS on “Protection of Undisclosed Information” is absolutely essential and in the public interest. Further as elaborated in co-sponsors document IP/C/W/684, copyright and industrial designs may also create obstacles for production and supply medical, and so these concerns also have to be addressed.
While the specific details of the current consultations/negotiations are not public, we would like to stress that any Waiver outcome has to create a clear pathway that provides potential manufacturers the full freedom to operate to manufacture, to import and export, and to commercialize needed COVID-19-related medical products without having to deal with procedural and legal IP requirements, on a product-by-product basis. The waiver decision should also accord governments policy space to implement measures necessary to facilitate production, import and export of medical products and their components.
Further the duration for the waiver outcome should reflect the current unpredictable complex situation with respect to COVID-19 (e.g. possibility of new, more lethal variants, uncertainty over duration of vaccine immunity, vaccine effectiveness against new variants) and the need to motivate diversified production and expand supply options especially in developing and least developed countries. In this regard, we support the proposal of TRIPS waiver co-sponsors in IP/C/W/669/Rev.1.
The WTO should also learn mistakes from its past. The cumbersome requirements of Article 31bis mechanism have resulted in an inflexible and unwieldy mechanism, unsuitable for promptly addressing urgent challenges of access. Hence, attaching conditions to the TRIPS waiver outcome under the pretext of transparency and that complicates the application of the waiver or limits its use to some Members will only further undermine the already rather fragile credibility of the WTO.
The time for excuses is over. Billions of people around the world are waiting for the WTO to deliver a bold outcome that will effectively and concretely contribute to enabling production in and expanding supply options towards realizing equitable access which is the key to socio-economic recovery.
Signatories
[1] https://www.hhs.gov/about/news/2021/06/17/biden-administration-invest-3-billion-american-rescue-plan-as-part-covid-19-antiviral-development-strategy.html
[2] https://ec.europa.eu/info/sites/default/files/communication-strategy-covid-19-therapeutics_en.pdf
[3] https://www.who.int/publications/i/item/WHO-WHE-2021.02
[4] https://www.huffingtonpost.co.uk/entry/european-union-covid-vaccine-intellectual-property-proposal_n_61664498e4b0f26084edbbff
[5] https://msfaccess.org/sites/default/files/MSF_assets/Access/Docs/ACCESS_briefing_NeitherExpeditiousNorSolution_WTO_ENG_2006.pdf
