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SOUTHNEWS

 
No. 367, 22 May 2021

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An overview of the growing legal measures and initiatives at national level and at the WTO to ensure access to Covid-19 vaccines
 

As the Covid-19 pandemic continues to ravage health systems, particularly in the global South, a growing number of legal and political mechanisms to foster access to vaccines, scale-up manufacturing capacity and promote technology transfer have been introduced across the world. While the policy space of developing countries which do not hold the technologies for Covid-19 vaccines (including the new mRNA platform) is in practice (though not de lege) more limited than in jurisdictions which may have control over such technologies, the growing list of adopted measures highlights the multiple attempts to address the stark inequalities in global vaccines allocation. It also elicits how demands for vaccine equality cannot be addressed with a single solution, but with a collective endeavor at multiple instances, of actors and countries. This text provides a glimpse of some of them.
 
As many scholars, health activists and organizations have expressed, to overcome this global pandemic all the following are needed: the proposal of a temporary waiver of certain provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)[1] (originally tabled by India and South Africa, now formally supported by the United States in an unprecedented move[2] and co-sponsored by 62 delegations as of May 2021[3]), technology transfer for manufacturers around the world with capacity to expand production, governmental and international funding for those endeavors, and combatting anti-competitive and abusive practices at the national levels. The idea that ‘no one is safe until everyone is safe’, repeatedly reminded by World Health Organization (WHO) Director-General, Dr. Tedros Adhanom, should not be taken lightly. Countering the role of corporate exclusivities over technologies that are ‘global public goods’, which were widely financed by public money in early research, clinical trials and pre-purchase agreements, is what lies at the core of the initiatives and measures described below.
 
Compulsory licensing for Covid-19 vaccines and potential treatments
 
Since the beginning of the Covid-19 pandemic in early 2020, some countries adopted early on legal measures, or preparatory measures, for the use of compulsory licensing for potential treatments and vaccines. These continue to be envisaged and adopted up to date.
 
For example, Canada, Germany and Hungary temporarily amended their legislations to ensure facilitated procedures for compulsory licensing of Covid-19 potential treatments and vaccines at the very beginning of the pandemic. On 24 March 2020, Canada amended Bill C-13, which covered multiple topics of Covid-19 response, to enable the government (via the Commissioner of Patents) to issue a license and negotiate/pay compensation afterwards, a much more streamlined process than the previous legislation.[4] On 27 March 2020, Germany approved the “Epidemic Preparation Act” enabling the Ministry of Health to issue compulsory licenses, also substantially reducing existing bureaucratic constraints.[5] Hungary issued Governmental Decree No. 212/2020 on 16 May 2020 to also enable the Hungarian Intellectual Property (IP) Office to issue a compulsory license after a communication of the Hungarian pharmaceutical regulator in relation to domestic needs to tackle a health emergency situation.[6]
 
Furthermore, compulsory licenses were indeed issued. Israel issued a compulsory license for Kaletra (ritonavir/lopinavir), a then early treatment candidate, in March 2020. Hungary and Russia issued compulsory licenses/government use for Remdesivir in October and December 2020, respectively. Ecuador issued a compulsory license for Raltegravir in 2021.[7]
 
In addition to that, parliamentary demands for, or preparatory measures to issue compulsory licenses were made or adopted in some Latin American countries. Ecuador’s Parliament issued a Resolution to request the government to issue compulsory licenses for all relevant products for Covid-19 on 20 March 2020. Colombia approved a Public Interest Decree in relation to all vaccines and treatments, as early as 25 March 2020, as a preparatory step for eventual Covid-19 compulsory licensing. Chile’s Parliament approved on 17 March 2021 Resolution 896 to declare of public interest all medicines and vaccines for Covid-19, also as preparatory steps for the issuance of compulsory licenses. This follows an original proposal in October 2020 for a similar resolution (Resolution Draft 1351).
 
On 30 April 2021, draft bill 12/2021[8] was approved by the Brazilian Senate to amend the Industrial Property Code provision on compulsory license (Article 71). It includes, among others: the possibility of granting ex officio a compulsory license on patents or patent applications, an obligation to consult public authorities, research institutes and civil society representatives on which patents or patent applications will be subject to a compulsory license, and the obligation by the patent holder/patent applicant to provide materials needed for manufacturing in the case of biological materials (which is the case of vaccines); failure to comply with this last requirement may entail revocation of the patent. The draft bill also declares the Covid-19 pandemic as a matter of national emergency and includes all Covid-19 vaccines (with the exception of those for which voluntary agreements already exist, i.e. Sinovac-Butantan and Astrazeneca-Fiocruz) and Remdesivir in the list for potential compulsory licenses (CLs).[9] To be approved, the Brazilian draft bill now would have to be voted by the Lower Chamber and sanctioned by the President. [10]

In India, multiple calls are currently being made for the licensing of the nationally developed Covaxin vaccine to other manufacturers beyond Bharat Biotech.[11] This vaccine was co-developed with and financed by the public Indian Council of Medical Research. Indian company Natco has also formally requested a voluntary license to produce Baricitinib, a potential treatment[12]; if the demand is unsuccessful, the condition of prior negotiation for the issuance of a compulsory license would be fulfilled. In parallel, the Delhi High Court has requested on 20 April that companies should immediately scale-up manufacturing of all products for the combat of the Covid-19 pandemic, already noting the possible issuance of a compulsory license in case they fail to do so (Delhi High Court – Orders, Rakesh Malhotra vs Government Of National Capital, 20 April 2021 - decision here).
 
In Canada, Biolyse Pharma Corp., an Ontario-based manufacturer of sterile injectable medicines, requested a voluntary license to Johnson & Johnson for the manufacturing of its vaccine for exporting purposes,[13] and has faced the procedural difficulties in utilizing the Canadian Access to Medicines Regime (CAMR) adopted to implement the waiver introduced by the World Trade Organization (WTO) Decision of 2003, particularly for addressing the urges of the pandemic.[14] Bolivia notified the WTO TRIPS Council of its intent to import 15 million doses of vaccines under article 31bis of the TRIPS Agreement.[15] Canada has now reportedly accepted to discuss the TRIPS waiver proposal after the aforementioned new position of the United States.[16]
 
Use of competition law
 
South Africa’s Competition Commission sanctioned in March 2020 two manufacturers of face masks for abuse of dominant position in cases of excessive pricing. Subsequent investigations continued to take place in the country since then.[17] Various other competition authorities, such as in Brazil and Peru, have launched their own investigations and have also clarified competition rules under the pandemic – including the guarantee by antitrust authorities that coordination between economic actors for supplying essential goods would not constitute an antitrust infringement.[18]
 
Political and legislative support to the TRIPS waiver
 
Several legislative chambers and parliamentary members have also passed motions, declarations or open letters to request their respective governments to support the proposal to waiver certain provisions from the TRIPS Agreement mentioned above. A few examples of such support include:
 
  1. European Union (EU): Joint Appeal by 388 Members of the European Parliament and of European National Parliaments Urging the EU and its Member States to Support a TRIPS Waiver
  2. Council of Europe: Council of Europe Resolution 2361/2021 - Covid-19 vaccines: ethical, legal and practical considerations, including support to overcoming intellectual property barriers (27 January 2021)
  3. African Union: African Union Doc. Assembly/AU/5(XXXIV) to support the TRIPS waiver proposal
  4. United States:  Letter of 10 US Senators to support the TRIPS waiver proposal (15 April 2021) – the USA would later formally support the proposal for negotiations on 5 May 2021
  5. South Korea: Proposal of Resolution in the Parliament to support the TRIPS waiver (2 April 2021)
  6. New Zealand: 42 organizations signed Public letter for New Zealand to support the TRIPS waiver (29 January 2021) – New Zealand would later formally support the proposal on 5 May 2021, pursuant to the formal positioning of the USA[19]
  7. Holy See (Vatican): Pope Francis supported the TRIPS waiver in a video statement, urging for the end of vaccine individualism (8 May 2021)[20]
 
These are only a few examples of a much wider support by international organizations, civil society organizations, high-level politicians, and the general public. These include an Open Letter by 250 civil society organizations (CSOs) in support of the TRIPS waiver to the new WTO Director-General Ngozi Okonjo-Iweala[21]; the People's Vaccine Initiative, a coalition of numerous civil society organizations, international organizations, and high-level politicians[22]; and a letter of 28 CSOs for Malaysia to support the TRIPS waiver (4 April 2021).[23] A more comprehensive list can be found here: https://www.twn.my/title2/intellectual_property/trips_waiver_proposal.htm.
 
The TRIPS waiver proposal
 
On 5-6 May 2021, the WTO General Council continued to discuss the TRIPS waiver proposal (IP/C/W/669). India and South Africa, the two original proponents, will revise the original proposal to address issues raised by various WTO Members so far.[24] As noted above, the United States expressed its support to the waiver proposal, noting that it would “actively participate” in text-based negotiations.[25] New Zealand supported the waiver shortly afterwards.[26] The text-based negotiations, however, may be challenging. Despite the support of some European governments, Germany, for example, continues to oppose it.[27] To be effective, the waiver should not only cover vaccines and patents, but all products, including treatments and diagnostics, as well as trade secrets, copyrights, and other forms of IP. Its specific scope and other aspects of the waiver need to be promptly agreed upon to allow for a rapid response to the pandemic.
 
Author: Vitor Henrique Pinto Ido is Programme Officer of the Health, Intellectual Property and Biodiversity Programme (HIPB) of the South Centre.
 
[1] Waiver from Certain Provisions of the TRIPS Agreement for the Prevention, Containment and Treatment of Covid-19. Communication from India and South Africa, IP/C/W/669, 2 October 2020, Available from https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W669.pdf&Open=True.
[2] See United States Trade Representative (USTR) Statement from Ambassador Katherine Tai on the Covid-19 Trips Waiver, 05 May 2021: https://ustr.gov/about-us/policy-offices/press-office/press-releases/2021/may/statement-ambassador-katherine-tai-covid-19-trips-waiver.
[3] The co-sponsors are: South Africa, India, Kenya, Eswatini, Mozambique, Pakistan, Bolivia, Venezuela, Mongolia, Zimbabwe, Egypt, the African Group, the Least Developed Countries (LDC) Group, Maldives, Fiji, Namibia, Indonesia and Vanuatu. See: https://www.wto.org/english/news_e/news21_e/trip_30apr21_e.htm.
[7] See South Centre, Scope of Compulsory License and Government Use of Patented Medicines in the Context of the Covid-19 Pandemic (March 2021). Available from https://www.southcentre.int/wp-content/uploads/2021/03/Compulsory-licenses-table-Covid-19-2-March.pdf.
[8] See the original text and justification of the draft bill here, in Portuguese only: https://legis.senado.leg.br/sdleg-getter/documento?dm=8961493&ts=1619817034824&disposition=inline. The Bill’s Rapporteur, Senator Nelsinho Trad, noted that “the aim of the bill is to save lives”, in accordance with the right to health recognized in the Constitution (page 12). The submission of the Bill also further explicitly noted that it would not prevent transfer of technology agreements nor derogate the obligation of the Executive Power to engage in international cooperation to make access viable (page 10).
[9] An earlier draft bill, proposed by Senator Paulo Paim, was more explicit in waiving the TRIPS Agreement at the domestic level for copyrights, industrial designs, patents and undisclosed information, and creating an obligation for holders of Covid-19 health technologies, such as vaccines, to share all relevant and necessary knowledge and know-how for the effective manufacturing of vaccines. Prior to that, a multi-party draft to facilitate the procedures for the issuance of compulsory licensing of Covid-19 treatments and vaccines had been proposed in mid-2020 by parliamentarians from all political spectra (PL 1462/2020). Also see, regarding the previous draft bill: Calixto Salomão Filho and Vitor Henrique Pinto Ido, “Como garantir que vacinas e tratamentos para a Covid-19 sejam acessíveis, Veja Saúde, 17 August 2020. Available from  https://saude.abril.com.br/blog/com-a-palavra/como-garantir-que-vacinas-e-tratamentos-para-a-covid-19-sejam-acessiveis/.
[10] Support for the waiver has been expressed by various non-governmental organizations (NGOS) and academics (see, for example, Jorge Bermudez, “O que podemos fazer hoje para evitar um apartheid sanitário global”, The Intercept, 5 May 2021. Available from https://theintercept.com/2021/05/05/o-que-podemos-fazer-evitar-apartheid-sanitario-globa-vacinasl/). The Brazilian government has communicated, after a shift in US position on the matter, its own position on the TRIPS waiver and a possible ‘third way’ in a joint statement by the Ministry of Foreign Affairs, the Ministry of Economy, the Ministry of Health and the Ministry of Science, Technology and Innovations. The Ministry of Foreign Affairs, Ministry of Economy, Ministry of Health and Ministry of Science, Technology and Innovations Joint Note 56, 7 May 2021. Available from https://www.gov.br/mre/pt-br/canais_atendimento/imprensa/notas-a-imprensa/vacinas-e-patentes-2013-nota-conjunta-do-ministerio-das-relacoes-exteriores-do-ministerio-da-economia-do-ministerio-da-saude-e-do-ministerio-da-ciencia-tecnologia-e-inovacoes.
[11] See, for example: Prabhash Ranjan, “Voluntary licensing of Covaxin will boost vaccine production, 04 May 2021. Available from https://www.hindustantimes.com/opinion/voluntary-licensing-of-covaxin-will-boost-vaccine-production-101620130941033.html; see also: Monika Yadav, “ICMR ready to offer Covaxin know-how to other firms, 7 May 2021. Available from https://www.thehindubusinessline.com/news/icmr-ready-to-offer-covaxin-know-how-to-other-firms/article34501232.ece.
[12] See: “Natco Pharma Files Application Seeking Compulsory License For COVID Drug Baricitinib”, 5 May 2021. Available from https://www-livelaw-in.cdn.ampproject.org/c/s/www.livelaw.in/amp/news-updates/natco-pharma-files-application-seeking-compulsory-license-for-covid-drug-baricitinib-173627.
[13] See: Arianna Schouten, “Canada based Biolyse Pharma Seeks to Manufacture COVID-19 Vaccines for Low-Income Countries, may test Canada’s compulsory licensing for export law”, Knowledge Ecology International, 12 March 2021. Available from https://www.keionline.org/35587.
[14] On the problems with the provisions related to compulsory licenses for export to countries without manufacturing capacity under Article 31bis of the TRIPS Agreement, see Carlos Correa, “Will the Amendment to the TRIPS Agreement enhance access to medicines? Policy Brief, No. 57 (Geneva, South Centre, January 2019).
[16] See: Sarah Turnbull, “Canada inches closer to waiving intellectual property rights on vaccines, amid political pressure”, 6 May 2021. Available from https://www.ctvnews.ca/politics/canada-inches-closer-to-waiving-intellectual-property-rights-on-vaccines-amid-political-pressure-1.5417078.
[17] See J Oxenham, MJ Currie, C van der Merwe, “COVID-19 Price Gouging Cases in South Africa: Short-term Market Dynamics with Long-term Implications for Excessive Pricing Cases”, Journal of European Competition Law & Practice (2020).
[18] See South Centre & IDEC Webinar, “Fair and Equitable Pricing in Health: Competition Law and Access to Medicines”, 3-4 December 2020. Available from https://www.youtube.com/watch?v=9WKug1mZEvY&list=PLZdHFQBFVjThTBeKtmswACPeSAoaqzMbq.
[20] Joe McCarthy, “Pope Francis Calls for Universal Access to COVID-19 Vaccines and Lifting of Patent Restrictions”, 8 May 2021. Available from https://www.globalcitizen.org/en/content/pope-francis-covid-19-vaccines-vax-live/.
[24] See: Elaine Ruth Fletcher,. “BREAKING – US Swings Weight Behind Global IP Waiver On COVID Vaccines; WTO Inches Towards ‘Text-Based’ Negotiations”, Health Policy Watch, 5 May 2021. Available from https://healthpolicy-watch.news/south-africa-wto-members-inch-towards-text-based-negotiations/.
[25] USTR statement, op cit.
[26] See footnote 19.
[27] See Financial Times, “Angela Merkel rejects US move to waive patents on vaccines”, 6 May 2021. Available from https://www.ft.com/content/76a05a85-b83c-4e36-b04d-7f44f63e57b0.
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