Intellectual Property: Barrier for affordable vaccines globally?

Currently, the biggest issue is not access to COVID-19 vaccinations, treatments or cures, but the lack of any licensed vaccines, treatments or cures to which they have access. Therefore, again still at this point, the policy priority of governments should be on promoting research and innovation that will deliver a vaccine, medication or cure. The first task with regard to access is to recognize the obstacles to access. There are many access obstacles, such as a lack of processing capacity for absolutely essential medical equipment and supplies, impediments to the cross-border movement of such supplies and equipment, import taxes, a lack of internal transport and distribution networks, and a lack of sufficient infrastructure and health systems. The World needs to overcome these hurdles. Intellectual property (IP) can also necessarily constitute an access barrier if innovation yields productive results and countries are unable to acquire innovation on fair and inexpensive terms. In this regard, there are arrangements at national and international levels. In other words, the implementation of these provisions should be targeted and time-bound, explicitly relating to the established IP obstacles to access in the course of the COVID-19 pandemic and keeping in mind that there will be little to access without creativity levels to promote access where IP is an obstacle.

Pardon International and Human Rights Watch[1] suggested ahead of a very crucial World Trade Organization (WTO) meeting in Geneva on December 10, 2020, governments should avoid blocking a temporary waiver of certain global rules on intellectual property that will help improve global access to Covid-19 vaccines. The waiver plan, if implemented, would encourage more governments to fulfill their responsibilities to respect the right to life and health.[2] The waiver plan, if implemented, would encourage more governments to fulfill their responsibilities to respect the right to life and health. The call comes as Covid-19 vaccinations start in the UK, and are likely to begin in the near future in other nations. Many lawyers argue that creativity has always been fostered by the robust IP regime and that is why countries should cooperate. Pharmaceutical firms claim they plan to collaborate in an unparalleled manner with competitors to help find solutions. Companies such as GlaxoSmithKline have already said they do not plan to benefit from Covid-19 vaccine partnerships during this pandemic.[3] "IP has allowed businesses to help-there is no suggestion that during the crisis it was a blocker," tells Nicole Jadeja, partner at Pinsent Masons.[4] There has been a lot of criticism about IP and patents in the past, but there have always been these problems and the model we have at the moment promotes research and development. Yet some would like to see businesses move a step further. Governments including Chile, Israel and Ecuador have already suggested that the coronavirus pandemic warrants the use of compulsory licenses for coronavirus technology-related patents.[5] Such initiatives enable governments to license the use of a patented invention without the permission of the patent holder to a third party or government entity. Backed by more than 30 nations, including Brazil, Norway and Costa Rica, the WHO has introduced a voluntary Covid-19 Technology Access Pool (C-TAP) aimed at sharing coronavirus research and enabling vaccines and tests freely accessible.[6]

Ellen't Hoen, director of the Medicines Law & Policy research group, says the IP monopoly model has in the past helped pharmaceutical companies but is not the way forward for the solutions needed to fight coronavirus. She adds that government agencies and aid bodies spend so much money on research and development, but there are also no conditions for this funding to have strings attached. “The finance for the innovation here has been given upfront . . . There is no need to make a profit from Covid-19 as development here has been paid for by public money”.[7] But while billions of dollars of investment are on the lookout for a solution for Covid-19, there are concerns as to whether the economic downturn will see struggling businesses cut back on their research and development in badly affected sectors such as aviation or engineering. Governments have a responsibility to ensure that the benefits of scientific research are shared by all countries and not to compete with the ability of other countries to satisfy their rights to health and life obligations. This involves obtaining access to medical products and medications, including vaccines, required to react to Covid-19. The Tweet by “We can only put an end to Covid-19 if governments recognize their human rights obligations and ensure that those most in need of life-saving vaccines are not left behind,” [8]Tamaryn Nelson, an advisor to Amnesty International on the right to health, said.“Agreeing to the TRIPS waiver is a crucial way for states to demonstrate that they are fully committed to immediately doing whatever is necessary to protect the right to health of billions of people, no matter where they live.”[9]

The proposal for a joint waiver, if accepted by India, South Africa, Kenya, Eswatini, Mozambique and Pakistan, would grant the WTO Member States the freedom to suspend the security and compliance of certain forms of intellectual property rights relating to copyrights, industrial designs, patents and trade secrets relating to the prevention, confinement or treatment of Covid-19.[10] The main objective of the waiver proposal is to promote the accessibility at an affordable price of Covid-19 medical items, such as personal safety devices, diagnostics, vaccines, medicines and other medical devices such as ventilators, by scaling up production by multiple suppliers. Legally, the security of IP forbids other parties from producing or using products/technologies covered by IP without the permission of the owner of the IP.[11] This legal ban prevents market competition and leads to insufficient availability of medical goods and high prices. Availability of these pharmaceutical products in greater numbers at reasonable prices is needed for an effective response to Covid-19. The suspension of protection and compliance of the various types of IP will allow countries to make it possible for manufacturers and innovators to freely use/produce IP-protected technology/products and to build competition and affordability in the medical products market for Covid-19.

WHO Chief Tedros Adhanom Ghebreyesus even said the vaccines, tests and therapies used to battle Covid-19 will be given a green light from their Geneva neighbors at the WTO, “available to all who need them at an affordable cost”[12]. Leena Menghaney, MSF's South Asia Medicines Access Campaign Manager, said that the initiative will "scale up production in many, many developing countries which have the capacity".[13] In addition to India and South Africa, she claimed that Bangladesh, Brazil, Thailand and many Latin American countries had production capacities. The decision, however, remains with the member states of the WTO, which generally take decisions by consensus. Thomas Cueni, president of the International Federation of Pharmaceutical Manufacturers and Associations, said that IP rights foster a "strong innovation business model"[14] that has enabled Covid-19 tools to be created. After being formally addressed on Thursday to the WTO TRIPS Board, currently headed by South Africa, the WTO General Council — the sole decision-making body of the organization — will also be discussed on 16 and 17 December. So, after that discussion[15], the TRIPS Agreement and the flexibility it provides will answer the questions posed in the TRIPS Council debate. In the first instance, TRIPs offer the possibility of issuing compulsory licenses. It is necessary to remember that, without the permission of a patent owner, this is done by governments. It also involves the possibility of granting fast-track licenses where no negotiations with the patent holder are needed, including for exports to countries where production capacity is inadequate or insufficient. These are completely legal instruments for members in need, and I want to be very transparent about that, since we are in the midst of this pandemic. Within 12 months of the first symptoms of the virus, vaccines will be accepted. Such a procedure will usually take 10 years. Only last May, credible scientists predicted that the most promising scenario for a vaccine to be developed and accepted was a lead time of 18 months. We've only been about six months since that time. Over 1000 new drugs and vaccines have been estimated to be in progress. Much of this response, such as vaccines based on mRNA technology, for example, builds on the expertise and research ability built over many years with the help of IP incentives. Japan, the United States and the European Union expressed their opposition during the informal discussions on the subject held in recent weeks at the WTO[16], highlighting the vast financial commitments made by the pharmaceutical groups. Such countries also insist that those who have produced vaccines are in the best position to manufacture them safely in the necessary quantities, a trade official from Geneva said[17]. The opponents of the proposal also argue that the new IP regulations are already adequately flexible,[18] with provisions for the issuance of compulsory licenses expressly intended for emergencies such as the coronavirus pandemic. Indeed, the existing rules permit the issuance of a so-called 'compulsory' license [19], authorizing the authorities, subject to certain conditions, to grant permission to produce a product to firms other than the patent holder. Some nations, however, claim that the process for obtaining such licenses is too complicated and the requirements too numerous. Since each request must be dealt with on a case-by-case basis, in order to help resolve bureaucratic challenges, they recommend a general exemption during the pandemic.

Rising tension from developing countries at the WTO could give the administrations of rich countries power to negotiate cheaper medicines and vaccines internationally with their pharmaceutical companies. The right thing to do in the face of a global pandemic is to rely on those companies; it is also the safest way for rich-country governments to take care of their own communities, which in some cases suffer more extreme drug shortages than people in far less prosperous countries do. Last month, the Wall Street Journal editorial board criticized the TRIPs waiver proposal put forward as a "patent heist" by India and South Africa, noting that "their effort would harm everyone, including the poor." In essence, if only the rich could see that, the effort would help everyone, including the rich.[20]

OPINION:

Several developing countries have invited other representatives of the World Trade Organization (WTO) to join them in a sweeping waiver of intellectual property (IP) rights relating to these vaccines, as a sign of their growing discontent with global efforts to ensure that all people worldwide have access to COVID-19 vaccines. Their waiver request reiterates the persistent debate within the WTO about the correct balance between the protection of IP rights and access to desperately needed medicines in poorer countries. The last thing that the WTO wants, however, is another discussion on perceived trade barriers to public health. It cites the "exceptional circumstances" caused by the pandemic and claims that the security of intellectual property currently "impedes or potentially impedes the timely provision of affordable medical products"; the waiver will enable W.T.O. member countries to amend their laws so that generic versions of any coronavirus vaccines and treatments for Covid-19 may be developed by companies there.

South Africa cited Regeneron and Eli Lilly, for example, who have already committed much of their COVID-19 cocktail antibody drugs to the US. In India, Pfizer has legally blocked Médecins Sans Frontières alternative pneumococcal vaccines from (MSF). Pfizer has compelled SK Bioscience to stop manufacturing its pneumococcal conjugate vaccine in South Korea (PCV).To be sure, for creativity, patents are not required, with the Harvard Business Review illustrating that IPR law actually stifles it. In the meantime, The Economist condemned patent trolling, which reduced the investment of venture capital in start-ups and R&D spending, especially by small firms.

[1] Human Rights Watch is an international non-governmental organization, headquartered in New York City, that conducts research and advocacy on human rights

[2] Members to continue discussion on proposal for temporary IP waiver in response to COVID-19(https://www.wto.org/english/news_e/news20_e/trip_10dec20_e.htm)

[3] Sanofi and GSK to collaborate on COVID-19 vaccine development (https://www.europeanpharmaceuticalreview.com/news/116913/sanofi-and-gsk-to-collaborate-on-covid-19-vaccine-development/)

[4] Coronavirus: patents rights and the public interest (https://www.pinsentmasons.com/out-law/analysis/coronavirus-patents-rights-public-interest)

[5]The key covid-19 compulsory licensing developments so far (https://www.iam-media.com/coronavirus/the-key-covid-19-compulsory-licensing-developments-so-far)

[6] Commitments to share knowledge, intellectual property and data (https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/covid-19-technology-access-pool)

[7]Medicines law and Policy (https://medicineslawandpolicy.org/)

[8] URGENTLY WAIVE INTELLECTUAL PROPERTY RULES FOR VACCINE (https://infojustice.org/archives/42857)

[9] Urgently waive intellectual property rules for vaccine (https://www.amnesty.org/en/latest/news/2020/12/urgently-waive-intellectual-property-rules-for-covid-19-vaccine/)

[10] No consensus at WTO on India, South Africa’s proposal to waive IP rights on Covid vaccines(https://theprint.in/diplomacy/no-consensus-at-wto-on-india-south-africas-proposal-to-waive-ip-rights-on-covid-vaccines/564654/)

[11] 5 —Protecting Digital Intellectual Property: Means and Measurements (https://www.nap.edu/read/9601/chapter/7)

[12] WTO deadlock on plan to free Covid vaccines from IP protection (https://medicalxpress.com/news/2020-12-wto-wrangle-covid-vaccines-ip.html)

[13] WTO wrangle on Covid vaccines IP idea (https://sg.finance.yahoo.com/news/wto-wrangle-covid-vaccines-ip-141746660.html?guccounter=1&guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAAH_TO56I3qkz28D95jdBDh0u1AUZPX9zy1k39cNYYB_fjMLjNVo9pvGmlZWiUOgej2uCJ03E2cij2KwCsAm6LVqqfWjgyNPMNAoWr1wQPNF41fXXr39g2Q9-rC0wAGNNO9Sj_rWWjSS_C-aE-SZr14jl-bwMV5tvpYgABYUIE9qj)

[14] WTO deadlock on plan to free Covid vaccines from IP protection(https://finance.yahoo.com/news/wto-wrangle-covid-vaccines-ip-141737572.html)

[15] EU Statements at the WTO General Council, on 18 December 2020(https://eeas.europa.eu/delegations/world-trade-organization-wto/90872/eu-statements-wto-general-council-18-december-2020_en)

[16] European Union (formerly EC) news archive (https://www.wto.org/english/news_e/archive_e/country_arc_e.htm?country1=EEC)

[17] “Whoever Finds the Vaccine Must Share It”(https://www.hrw.org/report/2020/10/29/whoever-finds-vaccine-must-share-it/strengthening-human-rights-and-transparency)

[18] COVID-19 Crisis and WTO: Why India and South Africa’s Proposal on Intellectual Property is Important(https://thewire.in/law/covid-19-crisis-wto-intellectual-property-vaccine-public-health)

[19]Compulsory licensing of pharmaceuticals and TRIPS(https://www.wto.org/english/tratop_e/trips_e/public_health_faq_e.htm)

[20]A Global Covid Vaccine Heist (https://www.wsj.com/articles/a-global-covid-vaccine-heist-11605829343)