1 The EU Vaccine Strategy on COVID-19 vaccine: the complex position of Intellectual
Property Rights within EU’s legislation.
By
Maria Luisa Polo Rubiales 12767352
THESIS SUBMITTED TO DR. THOMAS VANDAMME
In partial fulfilment of the requirements for an LLM degree in
EUROPEAN UNION LAW
UNIVERSITY OF AMSTERDAM 8 January 2021
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Table of content
Abbreviations: ... 3 Abstract ... 4 I. Methodology ... 5 II. Introduction ... 6COVID-19: Global Pandemic ... 6
Impact on our economies. ... 6
EU’s legal framework ... 8
III. EU Vaccine Strategy ... 9
The current situation about a potential COVID-19 vaccine: ... 9
The EU Vaccine Strategy: the APAs. ... 11
The EU Vaccine Strategy: A flexible and robust regulatory process ... 13
IV. IPRs within the EU legal’s framework ... 17
Intellectual property rights and its background ... 17
Legal recognition of a patent: IPRs within EU’s legal context. ... 18
The flexibility of IPRs in international law ... 20
V. EU Vaccine Strategy: the influence of IPRs. ... 22
IPRs international flexible mechanisms: ... 22
Pull mechanisms: ... 23
Open innovation ... 23
Reforming the patent system in biomedical products ... 25
VI. Conclusion ... 26
VII. Bibliography ... 28
3
Abbreviations
:
APA: Advanced Purchase Agreement
CFR: European Charter of Fundamental Rights EU: European Union
IA: International Agreement. IP: Intellectual Property
IPRs: Intellectual Property Rights MS: Member State
SME: Small and Medium Enterprise
TRIPS: The Agreement on Trade-Related Aspects of Intellectual Property Rights WHO: World Health Organisation
WIPO: World Intellectual Property Organisation WTO: World Trade Organisation
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Abstract
Since March 2020, the WHO has declared the COVID-19 as a global pandemic. The EU has been highly affected by it. The health care systems and economics of all Member States have been severely impacted. This thesis will discuss the EU Vaccine Strategy: in which way IPRs are potentially being used in order to tackle the global pandemic. It will at the same time question the current IPRs system..
The current situation shows tensions among EU regulations, such as the right to intellectual property (article 17 parag.2). Indeed, if the main priority, as stated in the EU Vaccine Strategy, is to ensure equitable and universal access to a future vaccine against COVID-19 as fast as possible, this thesis will assess how IPRs flexible mechanisms accelerated this process. This thesis will focus on how the EU Vaccine Strategy can use IPRs to accelerate the development of a vaccine while guaranteeing the safety and security of its citizens. It acknowledges how IPRs can lead to the monopoly of a big company. It then argues for the need of a strong European and international cooperation to focus on how regulations need to be issued now to manage intellectual property rights in order to ensure universal, equitable access to the vaccine as well as enough supply; without compromising fundamental rights. It is done by first explaining the main goals and the functioning of the EU Vaccine Strategy, then by analysing the current IPRs system and finally, by assessing which IPRs flexible mechanisms can be used to accelerate the creation of the COVID-19 vaccine within the EU Vaccine Strategy. The final part of the thesis will attempt to list a few possibilities given by the doctrine but also economists on how to issue IP regulations, taking into consideration fundamental rights as well as the current patent legal system in order to provide a universal vaccine as soon as possible.
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I.
Methodology
Since March 2020, the World Health Organisation has declared the COVID-19 as a global pandemic. Europe has been heavily affected by this pandemic; from an economical, societal, political, and also legal point of view. The European Union is showing strong flexibility in order to tackle the pandemic. One of its answers is the EU Vaccine Strategy Plan issued by the Commission. This thesis intends to provide an overview of the complex relationship between the current EU legislation and IPRs in the current global pandemic. During the pandemic, this tension is more visible than ever as patenting the first vaccine for COVID-19 is one of the main priorities of the international scene. In order to give a strong response against COVID-19, the EU has issued the EU Vaccine Strategy, which is an extraordinary effort to ensure a safe, affordable and accessible COVID-19 vaccine for all citizens in the EU. However, this strategy plan has been possible using flexible regulations. The goal of this thesis is to see how the EU Vaccine Strategy Plan balanced EU regulations on health and safety and how Intellectual Property Rights would influence this balance.
In order to do so, I will study the relevant EU reports which highlight the tension IPRs create within EU’s legislation. It seems however important to point out that this thesis is based on a very recent topic and that no case law mentioned in this thesis will be related to the current global pandemic, due to the lack of data. The idea is to take a look at existing doctrine and case law which deals with similar tensions and see the position of the European Union. Then, I will analyse the actual patent law system, which is very much based on international law and see the importance of IPRs within EU legislation. Then, I will take a look into how the EU Vaccine Strategy affects article 17 (2) of the Charter of Fundamental Rights and other EU legislation. Finally, I will discuss how IPRs and alternatives of IPRs mechanisms given by the doctrine can solve these tensions.
Then I will abandon the external and descriptive perspective to use an internal and evaluative perspective in order to make possible recommendations.
To write this thesis, I used different sources, however, due to the fact the global pandemic is still going on, I based most of my arguments on reports issued by different international organizations. I also used academic articles, EU law books, EU institutions websites, EU documents from different institutions (regulations, reports, decisions, etc…), relevant jurisprudence (CJEU’s judgements, Advocate General’s Opinions), newspapers and doctrine articles.
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II. Introduction
COVID-19: Global Pandemic
In March 2020, the World Health Organisation (WHO) declared that the COVID-19 virus was a global pandemic. The 12th of March 2020, the WHO placed the European region as the centre of this pandemic1. Currently, there are 3 874 181 active cases in the EU/EEA2 and since the beginning of the pandemic, 194 147 persons died directly because of COVID-19. The Netherlands has 155 6303 active cases. Worldwide, there are 36 561 936 active cases and 1 062 624 deaths directly attributed to COVID-194.
These high numbers give a rough idea of how urgent the situation is. However, the current situation goes beyond that.
The outbreak of the COVID-19 virus causes extreme, major, and new challenges to our economies, societies, politics, policies and regulations. Even though the COVID-19 impacted every economy worldwide, this paper will mainly focus on the impact it had in the European Union.
Impact on our economies.
In the European Union, a study conducted by the European Commission’s JCR, “suggests a 13.1% reduction in EU GDP in 2020 and a fall in consumption and investment of 14.9% and
1World Health Organization, Regional office for Europe. “WHO announces COVID-19 outbreak a pandemic”
Health emergencies topic. 12.03.2020 (URL:
https://www.euro.who.int/en/health-topics/health-emergencies/coronavirus-covid-19/news/news/2020/3/who-announces-covid-19-outbreak-a-pandemic), accessed on 05.08.2020
2 European Center for Disease Prevention and Control. “COVID-19 situation update for the EU/EEA and the
UK, as of 9 November 2020” Situation updates on COVID-19. (URL: https://www.ecdc.europa.eu/en/cases-2019-ncov-eueea), accessed on 06.11.2020
3 RIVM. National Institute for Public Health and the Environment “Current information about COVID-19 (novel
coronavirus)” Ministry of Health, Welfare and Sport. (URL: https://www.rivm.nl/en/novel-coronavirus-covid-19/current-information), accessed on 06.11.2020
4 Johns Hopkins University & Medicine “COVID-19 Dashboard by the Center for Systems Science and
Engineering (CSSE) at Johns Hopkins University (JHU)” (URL:https://coronavirus.jhu.edu/map.html), accessed on 06.11.2020
7 16.7%, respectively”5. They also say that in the absence of any EU action, the impact on EU employment would be devastating as the drop would be “about 12%”6.
To put this into perspective, SMEs represent 99% of European businesses7. The Commissioner Breton also mentioned the risks associated with this global pandemic “bankruptcies, layoffs, hostile takeovers, especially for the potentially most vulnerable actors in the chain, namely SMEs”8. Considering that the EU counts over 25 million SMEs that employ close to 95 million people in 20189, we can only imagine how devastating this will be for the economy and the employers/employees.
To illustrate the magnitude of the problem even further, in Germany: 58% of the SMEs experience a drop in turnover by 50% on an average, while in the Netherlands, 85% of SMEs are in financial difficulty because of the global pandemic and all its effect. In Portugal, 37% of the SMEs reported drop in production by at least 50% and in Belgium, 40% of companies reported a drop in revenue of 75% or more10.
This shows the emergency of the situation and the reason why the EU Vaccine Strategy was necessary and approved by all Member States.
A fast and efficient vaccine must be found. The EU Vaccine Strategy addresses this problem and is in charge of supplying the vaccine to the Member States, once a successful vaccine has been developed.
5Conte, A. Lecca, P. Sakkas, S. and Salotti, S “The territorial economic impact of Covid-19 in the EU. A
Rhomolo analysis” European Commission’s Joint Research Center. July 2020. (URL:https://ec.europa.eu/jrc/sites/jrcsh/files/jrc121261.pdf), accessed 09.10.2020
6Ibid
7Report by European Cluster Collaboration Platform “European SMEs and the Impact of COVID-19” June 2020. 8European Commission (24 April 2020) Speech of Commissioner Breton at the European Parliament Committee
on Industry, Research and Energy.
9 Report by European Cluster Collaboration Platform “European SMEs and the Impact of COVID-19” June
2020.
(URL:https://www.clustercollaboration.eu/sites/default/files/european_smes_and_the_impact_of_covid.pdf), accessed on 25.09.2020
10 OECD (2020) Coronavirus (COVID-19): SME Policy Responses (URL:
https://www.oecd.org/coronavirus/policy-responses/coronavirus-covid-19-sme-policy-responses-04440101/), accessed on 26.09.2020
8
EU’s legal framework
We have seen the urgency of this crisis and how it is threatening the current international and European order we know. By describing the magnitude of the problem, the idea is to show how now, more than ever, the European Union needs to work together in order to tackle this global pandemic. The EU needs to find a solution to end this global pandemic within its legal order. This means the EU needs to use existing legal tools to develop a framework in which the EU can end this pandemic. The only efficient way to end with this pandemic is to find a safe vaccine against the virus11.
Since the 21December 2020 a vaccine has been conditionally12 approved13 in the EU market. According to the normal procedure for the validation of a vaccine, it can take up to 10 years from the creation to the vaccine to the market authorization. One of the reasons why the process usually takes up to 10 years is because the number of regulations the vaccine needs to respect before being authorized in the market. A large number of IPRs mechanisms need for example to be respected, but also regulations on health, safety, security and internal market.
It seems then impossible that the Pfizer-BioNTech COVID-19 vaccine has been developed according to the normal process. The Commission is fully aware that the current legislation on the development and distribution of a vaccine does not match the will of the EU on having a vaccine within 12 to 18 months. The goal of this thesis is to see how the IPRs mechanisms used in the biomedical/pharmaceutical sector are outdated and see how in the COVID-19 case they have been used to facilitate the development of the vaccine.
11Communication from the Commission to the European Parliament, the European Council, the Council and the
European Investment Bank EU Strategy for Covid-19 vaccines Com/2020/245 final (URL: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1597339415327&uri=CELEX:52020DC0245), accessed on 09.09.2020
12 Definition of conditional marketing authorisation: “The approval of a medicine that addresses unmet medical
needs of patients on the basis of less comprehensive data than normally required. The available data must indicate that the medicine’s benefits outweigh its risks and the applicant should be in a position to provide the comprehensive clinical data in the future.” (URL: https://www.ema.europa.eu/en/glossary/conditional-marketing-authorisation).
13De Keersmaecker, S. and Meder, S. “Questions and Answers: Coronavirus and the EU Vaccines Strategy”
Press Relase, European Commission. 21.12.2020
9
III. EU Vaccine Strategy
The current situation about a potential COVID-19 vaccine:
Before discussing the EU Vaccine Strategy in depth, it is important to discuss the current global situation about a potential COVID-19 vaccine.
First, the development of a vaccine can take up to 10 years14 to be successful and available. Some optimistic estimations believe that a vaccine for COVID-19 can take between 12 to 18 15months to be worldwide available. Of course, this is assuming that one of the clinical trials turn out to be successful16. With the conditional market authorization of the BioNTech and Pfizer vaccine, these estimations ended up being real.
The EU as the rest of the world are mainly focusing on scientific research. However, even though it is necessary and essential to focus on scientific research, it is also crucial to focus on building a system that can produce, manufacturing and distribute this new potential vaccine. Indeed, health systems all over the world need to vaccine 50 to 75% 17 of the world’s population in order to end this pandemic18, this basically implies that 4 to 6 billion people need to be vaccinated. Therefore, planning massive vaccination campaigns is necessary. Which means there is an urgent need for countries to coordinate their national policies through international cooperation.
If we focus at the European level, cooperation between governments is needed to build these vaccine campaigns as they need to coordinate their policy to project the demand and plan supply chains which will provide enough vaccines quantities for all Member States.
Having a successful vaccine which would be authorized to be sell, does not mean that it will be immediately available for populations. Health care systems need to distribute enough quantity
14Communication from the Commission to the European Parliament, the European Council, the Council and the
European Investment Bank EU Strategy for COVID-19 vaccines. COM/2020/245 final
(URL: https://eurlex.europa.eu/legalcontent/EN/TXT/?qid=1597339415327&uri=CELEX:52020DC0245)
15 Ibid
16S. Scarpetta, M. Pearson, F. Colombo, E. Barrehno, G. Dedet, M. Wenzl. “Treatments and a vaccine for
COVID-19: The need for coordinating policies on R&D, manufacturing and access” OECD Policy Responses to Coronavirus (COVID-19). (URL: https://www.oecd.org/coronavirus/policy-responses/treatments-and-a-vaccine-for-covid-19-the-need-for-coordinating-policies-on-r-d-manufacturing-and-access-6e7669a9/#endnotea0z23)
17Flaxman, S. et al. Estimating the effects of non-pharmaceutical interventions on COVID-19 in Europe. Nature
https://doi.org/10.1038/s41586-020-2405-7 (2020).
10 of the vaccine at an affordable price. This means various suppliers need to produce the vaccine at a competitive price. This is a remarkable task. Estimations say that in Europe, in order to reach herd immunity, we need 50-75% of the population to get the vaccine19. It is therefore urgent that firms start thinking about manufacturing plan. However, this would be a huge risk for firms as the researchers for the vaccine are still at early stages, so no company wants to invest on a manufacturing plan, considering that they are not even sure the vaccine will be successful. No company will invest in such risk. This is why the EU needs to act as a public investor and EU cooperation is urgently needed. As if no one plan the supply of the vaccine before the marketing authorization, it can take several years to build sufficient quantity and make it available for all health systems, which would have an enormous impact on health and economic systems20. So, in order to avoid this situation, the EU Vaccine Strategy includes a part of the procurement and delivery of vaccine to populations. As European health care systems cannot afford to wait additional months or years due to this lack of regulation and coordination.
In order to respond to these concerns, the EU has issued the EU Strategy Vaccine. As stated in the strategy “Once a successful COVID-19 vaccine is available, hundreds of millions, or even billions, of doses will need to be produced in order to cover global needs, […]. Delivering such an undertaking within such a compressed timeframe requires running clinical trials in parallel with investing in production capacity”21
The EU has started to think about mechanisms in order to have an adequate production capacity of the vaccine.
19 S. Scarpetta, M. Pearson, F. Colombo, E. Barrehno, G. Dedet, M. Wenzl. “Treatments and a vaccine for
COVID-19: The need for coordinating policies on R&D, manufacturing and access” OECD Policy Responses to Coronavirus (COVID-19). ( https://read.oecd-ilibrary.org/view/?ref=133_133372-v717pcul4c&title=Treatments-and-a-vaccine-for-COVID-19-the-need-for-coordinating-policies-on-RD-manufacturing-and-access)
20S. Scarpetta, M. Pearson, F. Colombo, E. Barrehno, G. Dedet, M. Wenzl. “Treatments and a vaccine for
COVID-19: The need for coordinating policies on R&D, manufacturing and access” OECD Policy Responses to Coronavirus (COVID-19). ( https://read.oecd-ilibrary.org/view/?ref=133_133372-v717pcul4c&title=Treatments-and-a-vaccine-for-COVID-19-the-need-for-coordinating-policies-on-RD-manufacturing-and-access)
21Communication from the Commission to the European Parliament, the European Council, the Council and the
European Investment Bank EU Strategy for COVID-19 vaccines. COM/2020/245 final
11
The EU Vaccine Strategy: the APAs.
The main mechanism behind the EU Vaccine Strategy, is that the Commission, on behalf of all Member States, negotiated and concluded APAs (Advanced Procurement Agreements) with different companies which are vaccine producers. With these agreements, the Member States are securing a number of vaccine doses at a negotiated price with a given timeframe22. Under this strategy, once the vaccine has been successfully developed, all Member States will access it at the same time and the “distribution will be done on a per capita basis to ensure fair access”23. Which means these APAs are concluded in order to distribute the vaccine the population in the most effective way.
The BioNTech-Pfizer, which is to date, the only vaccine against COVID-19 that has been authorised and distributed in the EU has been acquired in accordance to the EU Vaccine Strategy. The Commission signed an APA between the company and the EU. However, the EU concluded six other APAs with different vaccine producers24 that will allow to purchase the vaccine once they passed all the EU safety and security regulations. The reason why the EU concluded and is still having exploratory talks with other companies, is because the EU needs a “broad portfolio of vaccine candidates based on different technological approaches to maximise the chances of quickly developing, manufacturing and deploying a vaccine for all Europeans”25. As mentioned above, various suppliers need to produce the vaccine at a competitive price.
The vaccine development is a complex and long process which takes around 10 years, or even more, if we think about the AIDS vaccine, which still does not have a successful vaccine. However, the BioNTech-Pfizer vaccine has been developed and is being distributed less than one year since the COVID-19 break out.
This has been possible thanks to one of the main pillars of the EU Vaccine Strategy: “Adapt the EU rules to the current urgency in order to accelerate the development, authorisation and
22 Report official EU website “ Coronavirus vaccine strategy” (
URL:https://ec.europa.eu/info/live-work-travel-eu/coronavirus-response/public-health/coronavirus-vaccines-strategy_en#what-the-eu-proposes) 07.01.2021
23 Ibid
24De Keersmaecker, S. and Meder, S. “Questions and Answers: Coronavirus and the EU Vaccines Strategy”
Press Relase, European Commission. 21.12.2020
(URL:https://ec.europa.eu/commission/presscorner/detail/en/qanda_20_2467)
12 availability of vaccines while maintaining the standards for vaccine quality, safety and efficacy”26.
In order to make the EU Vaccine Strategy efficient, the Commission issued several different legislations. Such as the decision of 18.6.2020, about approving the agreement with Member States on procuring Covid-19 vaccines on behalf of the Member States and related procedures. Such decision was for example the legal basis for the APAs. Where in paragraph 3 the Commission defined the main goal of these APAs “ In order to implement such action, the Commission has offered to run a single central procurement procedure on behalf of all Member States, with a view to signing EU level Advance Purchase Agreements (“APAs”) with vaccine manufacturers. Those APAs would include up-front EU financing to de-risk essential investments in order to increase the speed and scale of manufacturing successful vaccines (“Vaccine Instrument”). In return, the APAs would provide the right – or under specific circumstances the obligation – to Participating Member States to buy a specific number of vaccine doses within a given timeframe and at a given price”
In this decision, the Commission secured a big part of the supply of the vaccine. Indeed, these APAs are a a joint pooled procurement and seem like an efficient way to end this crisis as soon as possible27.
From a financial point of view, these APAs were funded via the ESI (Emergency Support Instrument)28. Under the ESI, the Parliament and the Council have made 2.7 billion available. The EU also secured an additional support from the EIB (European Investment Bank). The APAs seem to be an efficient pull mechanism in order to secure the supply and the access of the vaccine. Indeed, according to the EU Vaccine Strategy, they will use EU public funds as a deposit in the context of APAs. They will use these funds in order to purchase a potential COVID-19 vaccine29. In other words, they will use EU’s public money to compensate for the potential loss of investment these big pharmaceutical companies will lose if the vaccine is a failure30. So, this public money will be used to cover the investment these companies lost. In exchange, Member States will have priority, privileged access to the potential vaccine as well
26 Report official EU website “ Coronavirus vaccine strategy” (
URL:https://ec.europa.eu/info/live-work-travel-eu/coronavirus-response/public-health/coronavirus-vaccines-strategy_en#what-the-eu-proposes) 07.01.2021
27 Y. Natsis. “Getting it right: COVID19 vaccines procurement” European Public Health Alliance. 30.06.2020.
(URL:https://epha.org/getting-it-right-covid19-vaccines-procurement/)
28Communication from the Commission to the European Parliament, the European Council, the Council and the
European Investment Bank EU strategy for covid-19 vaccines. com/2020/245 final
29 ibid 30 Ibid
13 as the right to buy it, however, only in the future and only if the mentioned vaccine is authorized31. Now, this means the EU is acting as a public investor and that in the case at hand, the EU was the only actor willing to take such risk. Because there is a big risk to lose all this public money as there is no guarantee the negotiated vaccine in these agreements will be efficient32. Recently, we have seen these APAs seem to be successful as the “The Commission has given on 21 December the conditional marketing authorization for the vaccine developed by BioNTech and Pfizer, following EMA positive assessment of its safety and efficacy. It is now waiting for EMA's opinion on the possible conditional marketing authorization for the vaccine by Moderna, which should be provided by 6 January at the latest33”.
This will be developed further, but the interesting thing is that the EU acting as a public actor prevented big pharmaceutical companies to dictate the price of the medical supply. In the current patent system in the biomedical sector, usually big pharmaceutical companies dictate such things.
The EU Vaccine Strategy: A flexible and robust regulatory process
Considering the urgent situation, the main priority of the EU is to develop an effective and safe vaccine against COVID-19 as soon as possible. This will save lives but also billions of euros. In order to have access to this potential vaccine, the Commission proposed several solutions. The goal of this paper is to discuss these proposed solutions and see how IPRs are part of these flexible regulatory process.
As mentioned above, the development of a vaccine is a complicated process and takes in average 10 years. For the reasons already explained, it is simply not possible to wait this amount of time. The goal of the EU is to have a vaccine within 12-18 months. For that, the EU has issued a plan that consists of accelerating the authorisation of existing procedures. If the EU acknowledges that any decision concerning the vaccine should be backed up with sufficient data in order to ensure the safety of the patients and the efficacity of the vaccine, they also
31 Communication from the Commission to the European Parliament, the European Council, the Council and the
European Investment Bank EU strategy for covid-19 vaccines. com/2020/245 final
32 At the time I wrote this, the vaccine was not available.
33 De Keersmaecker, S. and Meder, S. “Questions and Answers: Coronavirus and the EU Vaccines Strategy”
Press Relase, European Commission. 21.12.2020
14 announced that they will use existing regulations which contain flexibilities clause in case of urgent situations.
By saying this, the Commission is announcing that they will use these flexible regulations in order to accelerate the authorisation and availability of a potential vaccine. There is a reason why these are regulations on developing and approving a vaccine. These regulations are made to ensure the highest pharmaceutical legal requirements, in terms of quality, safety and efficacity34. By accelerating these procedures, it could result in lowering the health standards and increase the risk of a negative benefit-risk balance. Meaning increasing the risk that the vaccine will be a failure and losing billions of euros and potentially thousands of lives. Therefore, reviewing the process of the development of a vaccine by speeding its development and potential approval could lead to this undesirable result. Moreover, it is important to remember that every piece of legislation issued by the EU has to respect EU primary law. If accelerating the development of a vaccine leads to lowering health standards, it could lead to a potential violation of article 35 CFR.
However, the EU, in recent communications, guaranteed that “Before approval, all vaccines in the EU are evaluated against the same high standards as any other medicine”. 35 Therefore, the regulatory standards which are based on safety, quality and efficacity must be approved according to the same standards applied to all EU’s medicines36. The main difference with the normal development of a vaccine is that clinical trials, which are done in three phases: phase I: human pharmacology studies. Phase II: therapeutic exploratory studies. Phase III: clinical efficacy and safety studies. These clinical trials will be carried out in a faster time frame (see fig.1)37. There is not enough data available yet to prove if safety standards have been reduced in the development of the vaccine. However, the EU committed to maintain higher quality, efficacy and safety standards while reducing the timeline of the development of the vaccine.
34 Report: COVID-19 vaccines: key facts. European Medicines Agency. Official EU-website. (URL:
https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/covid-19-vaccines-key-facts)
35Report: COVID-19 vaccines: key facts. European Medicines Agency. Official EU-website. (URL:
https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/covid-19-vaccines-key-facts)
36Report: COVID-19 vaccines: development, evaluation, approval and monitoring. Erupeam Medicines Agency.
Official EU website (URL:
https://www.ema.europa.eu/en/human-regulatory/overview/public-health- threats/coronavirus-disease-covid-19/treatments-vaccines/covid-19-vaccines-development-evaluation-approval-monitoring)
15 In its communication paper for the EU Strategy vaccine, the Commission announced that “clinical trials will be carried out within a remarkably compressed timeframe, thus limiting the data available for reviewing the market authorisation request”38. The marketing authorization refers to the approval to market a medicine in one, several or all European Union Member States39. Even though the data available will be reduced, the EU announced that “regulators can only approve the vaccine if its scientific evaluation of the tests results show that the vaccine’s benefits are greater than its risks.”40 According to the EU’s communication, the fast track vaccine development does not necessarily lead to reducing health standards. However, regulatory mechanisms need to be used in order to compress in time the development of a vaccine.
There is not enough available data that can prove which regulatory mechanisms have been used by the EU and the companies to develop the vaccine, as the APAs benefit from confidentiality clauses41 and the research work on the vaccine is protected by IPRs and is not accessible to the public.
However, one solution for reducing the timeline of these clinical trials can be done by using IPRs flexible mechanisms. In its EU Vaccine Strategy, the Commission announced that “the Commission will make the greatest use of these existing flexibilities to accelerate the authorization and availability of successful vaccines against COVID-19”42 .
Indeed, clinical trials can be speed up only if the scientific dispose enough scientific data and material. Which means that in order to ensure standards of quality, safety and efficacity during this process, it is essential to provide scientists with the latest data and technologies available. This was mentioned in the Strategy, when the Commission and EMA created the ETF (Task Force), “to interact with developers of COVID-19 vaccines and offer scientific support from the early stages of development.”43 In order to provide all these tools, IPRs flexibles must have
38Communication from the Commission to the European Parliament, the European Council, the Council and the
European Investment Bank EU Strategy for COVID-19 vaccines. COM/2020/245 final
(URL: https://eurlex.europa.eu/legalcontent/EN/TXT/?qid=1597339415327&uri=CELEX:52020DC0245)
39 Definition Market auhtorization by the European Medicines Agency. EU Official Website
(URL:https://www.ema.europa.eu/en/glossary/marketing-authorisation)
40EU Coomunication: Approval of vaccines in the European Union. European Vaccination Information Portal.
(URL: https://vaccination-info.eu/en/vaccine-facts/approval-vaccines-european-union)
41 European Commission. Coronavirus response: Public Health (URL:
https://ec.europa.eu/info/live-work-travel-eu/health/coronavirus-response/public-health_en)
42 Communication from the Commission to the European Parliament, the European Council, the Council and the
European Investment Bank EU Strategy for COVID-19 vaccines. COM/2020/245 final
(URL: https://eurlex.europa.eu/legalcontent/EN/TXT/?qid=1597339415327&uri=CELEX:52020DC0245)
43 Communication from the Commission to the European Parliament, the European Council, the Council and the
16 been used as indeed, the share of data, the use of the latest technologies and all this material requires patent approvals44.
This ETF provides “provides rapid scientific advice and feedback on development plans, offers scientific support to facilitate clinical trials conducted in the EU and a rolling review of incoming scientific data from clinical trials to allow for an accelerated assessment of the final data after completion of the clinical trials. This will facilitate and ultimately accelerate the development, assessment, authorisation and safety monitoring of vaccines45”. One of the suggestions of this thesis, is to see if these clinical trials have been accelerated thanks to IPRs mechanisms, such as the ones mentioned in the TRIPS (art 31 and 31 bis). These are flexible mechanisms of international IPRs and will be developed further.
The EU Vaccine Strategy also mentions the accelerated procedure for authorisation. The Commission announced they will use flexible EU regulatory systems which will be accommodate to the critical situation. So, the initial authorisation will be granted “on less comprehensive data than would normally be the case (though nonetheless with a positive benefit-risk balance), and with obligations on the marketing authorisation holders for the data to be completed afterwards”46.
It is according to this conditional authorisation system that the Pfizer vaccine has been approved47.
This thesis attempts to show how IPRs flexible mechanism have been potentially used in the EU Vaccine Strategy to allow the fast development of the vaccine. To have a clear idea of that, it seems important to first have an overview of how patent law works in the EU.
(URL: https://eurlex.europa.eu/legalcontent/EN/TXT/?qid=1597339415327&uri=CELEX:52020DC0245)
44 Ibid 45 Ibid 46 Ibid
47 EU Coomunication: Approval of vaccines in the European Union. European Vaccination Information Portal.
17
IV. IPRs within the EU legal’s framework
Intellectual property rights and its background
It seems important to first illustrate how intellectual property and the patent systems work. According to the definition of the WIPO, intellectual property refers to “creations of the mind”48, which can be literary and artistic work, designs, symbols, and inventions such as vaccines. So, IPRs protect all kind of ideas, from technological innovations to art. Through the doctrine, IPRs make a distinction between artistic creations and inventions. Artistic creations are protected by copyright and inventions by industrial property49. The distinction is important because in this paper, the main focus will be on patents protecting inventions50. As we will focus on “inventions”; it is important to define it; it is as an idea that can solve a technical problem. It can be transposed to the COVID-19 vaccine, as the “recipe” which will create the vaccine will solve the global pandemic. Once the idea is developed and becomes an invention, the State (or the competent legal institution) will confer the title that attest the exclusive rights or the grant to the inventor for the exploitation of their invention51. In other words, patents exist to incentivize inventions and innovations. They provide a limited-term monopoly to the creator which enables her/him to make profit before anyone else52. The duration of this monopoly is usually 20 years53. For example, it means that if the creator of the COVID-19 vaccine decides to patent it, he/she will have an exclusive right to sell, produce and distribute the vaccine for 20 years54. It is evident how these terms could be problematic in the current global pandemic. Another possibility provided by IPRs are licenses. The inventor can also choose to license its innovation, such as potential vaccine against COVID-19 and in exchange they receive royalties or license fees (or both)55. These licenses allow the buyer to exploit the innovation and sell it in a specific geographical area.
48 Definition of Intellectual Property by the WIPO (URL:https://www.wipo.int/about-ip/en/)
49S. Salazar. “Intellectual Property and the Right to Health”. Central American Economic Integration Secretariat
(SIECA) and WIPO. p7. 2001
50 Ibid, p.8 51 Ibid 52 Ibid, p. 16
53 Art 63 The European Patent Convention, 1977.
54 Dr Cassar, T., Dr Saliba, B., Sammut E,. “COVID-19 and its effects on Intellectual Property” Gtgadvocates.
17.04.2020 (URL: https://www.gtgadvocates.com/covid-19-and-its-effects-on-intellectual-property/)
55 WTO Analytical Index. Article 31bis of the Agreement on Trade-related aspects of Intellectual Property
18 Through this brief explanation, it is possible to see why IPRs are so important in the creation of a vaccine against COVID-19. In this context, IPRs or the patent for a vaccine against COVID-19 is of crucial importance as it would give the inventor the control over the production and distribution of the vaccines in the countries where the patent rights are granted56. This will be developed further, but the APAs solved part of this problem. The EU, by acting as a public investor, prevented part of the mentioned problem.
Legal recognition of a patent: IPRs within EU’s legal context.
The EU gives a crucial place to IPRs in its legislation and this can be seen through the increase number of regulations issued by the EU but also through the ECJ’s jurisprudence, dealing with IPRs and fundamental right cases.
The reason why IPRs have such an important place is because, as mentioned above, IPRs are created in order to stimulate innovation. Which means that if the EU wants to compete in the global economy, protection and enforcement of IPRs are essential. Their importance was clearly seen in the “A Single Market for Intellectual Property Rights – Boosting creativity and innovation to provide economic growth, high quality jobs and first class products and services in Europe” (COM (2011) 287)57 and Digital Agenda for Europe (COM (2010) 245)). There, the EPO/OHIM demonstrates that IPR-intensive industries contribute 39% of total economic activity worth some €4.7 trillion annually) and 26% of all employment in the EU (56.5 million jobs) (“Intellectual property rights intensive industries: Contribution to economic performance and employment in Europe”, September 2013)”58.
Moreover, in the past 20 years, the EU issues more than 100 of IP Directives and Regulations. General provisions of competencies permit to act only “in the light of the functioning of the internal market”59.
56 L. Hood. “Whoever invents a coronavirus vaccine will control the patent – and, importantly, who gets to use
it.” The Conversation. May 2020. (URL: https://theconversation.com/whoever-invents-a-coronavirus-vaccine-will-control-the-patent-and-importantly-who-gets-to-use-it-138121).
57 C. Geiger (ed.), Research Handbook on Human Rights and Intellectual Property (Edward Elgar,
Cheltenham/Northampton, 2015)
58Ibid
59 C. Geiger. “Shifting Centres of gravity in European IPR’s protection” Centre for International Intellectual
19 This shows the essential place of IPRs in EU’s legislation and policy. A priori, IPRs are only issued according to the internal market perspective. Which means, the social, political, philosophical, or humanitarian perspective seem to be left out. This could be problematic facing the current crisis.
Besides, on top of the internal market requirement while issuing IPRs legislation, the EU also needs to comply with international law and international obligations. This requirement is very important because as already mentioned, international agreements are part of EU’s primary law. which means that every piece of legislation regarding IPRs need to comply with EU’s international commitment.
It is important to mention that IPRs are highly influenced by principles of international law they must respect. For example, in order to grant a patent to an invention, the invention needs to comply with three universally recognized requirements60; which are novelty, inventive step and industrial applicability61.This is a general principle of international intellectual property law. Besides, the EU needs to comply with its international obligations regarding IPRs.
Meaning that EU’s legislation concerning IPRs cannot affect its international obligations. This means that the EU, in the context of finding a vaccine against COVID-19, still needs to comply with its IPRs’ international obligations. This could considerably limit the scope of application of new potentials IPRs during the coronavirus crisis.
However, due to the current crisis, the EU needs to act on IPRs as, it would allow to give too much power to a unique private company. This would mean, one company, in the world, would have the exclusive rights on the vaccine and therefore, control the production, pricing, distribution and supply of the vaccine which would end the global pandemic.
Moreover, the fact that the EU can only legislate about IPRs “in light of the functioning of the internal market” makes it very challenging for the current crisis. As, a priori, IPRs do not take into consideration social or political aspects.
It is evident that considering the current situation, the EU needs to take a different approach regarding IPRs, by taking into considerations other aspects that the internal market while complying with its international obligations.
60 S. Salazar. “Intellectual Property and the Right to Health”. Central American Economic Integration
Secretariat (SIECA) and WIPO. p,21. 2001
20
The flexibility of IPRs in international law
If IPRs international obligations can be seen as an obstacle within EU Vaccine Strategy, they can actually be a facilitator in accessing medical technologies or even in the creation of a new vaccine.
Before entering in a deeper analysis on how international IPRs can actually help in this crisis, it is important to highlight the reason why explaining the dangers of IPRs in the finding of a vaccine against COVID-19 is important. Indeed, IPRs could slow down the obtention, production and distribution of a vaccine for the reasons mentioned above and it is important to acknowledge the threats they can represent in the obtention of a COVID-19 vaccine. However, IPRs themselves, are not the problem, because they are very much needed to incentivize the economy is more how the companies and governments use these IPRs that can be problematic. So, the goal of this analysis is to show how IPRs influence the timeline of the development and distribution of the vaccine.
If one could think that the EU could see its margin of maneuver limited by international obligations regarding IPRs, it is important to mention that these IA could actually help in getting a vaccine as soon as possible without violating IPRs or fundamental rights. As mentioned in the key points of the WTO report looks at the global intellectual property system and COVID-19: “A full response to the COVID-19 crisis requires wide access to an extensive array of medical products and other technologies, ranging from protective equipment to contact tracing software, medicines and diagnostics, as well as vaccines and treatments that are yet to be developed”. The current IP system can be a facilitator in getting access to all this material and the TRIPS agreement is the legal basis for it62. The EU is bound by the TRIPS Agreement63. Which means that the EU Vaccine Strategy needs to comply with their obligations under the TRIPS64. The TRIPS Agreement “sets out the minimum standards of protection to be provided by each Member”65. It also deals with remedies for the enforcement of IPRs.
62 WTO-Report looks at the global intellectual property system and COVID-19 (URL:
https://www.wto.org/english/news_e/news20_e/trip_15oct20_e.htm)
63Corrigendum to Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the
enforcement of intellectual property rights (OJ L 157, 30.4.2004) OJ L 195, 2.6.2004, p. 16–25 URL: http://data.europa.eu/eli/dir/2004/48/corrigendum/2004-06-02/oj
64Ibid
65 Report: Overview the TRIPS Agreement. World Trade Organization. (URL:
21 This agreement, which is the “the most comprehensive multilateral agreement on IP”, recognizes the use of flexibilities mechanisms when granting a patent protection. It gives enough freedom to the Member States in applying such mechanisms in extreme cases, such as the protection of public health. The 2001 Doha Declaration on the TRIPS Agreement and Public Health confirmed that, “the Agreement can and should be interpreted and implemented in a manner support of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all.”66. These flexible mechanisms are found in article 30 and 31 of the TRIPS; they allow exceptions to existing patent protection and compulsory licensing67. Indeed, article 31 of the TRIPS allows compulsory license, which means that government and other companies can produce the patented product without the authorization of its owner. Thanks to the article, in case of a national emergency or circumstance of extreme urgency, they can get a compulsory license without trying to obtain the authorization from the owner. So, considering the current global pandemic, all governments of each Member States fulfil this requirement. This would mean that the EU can legally grant such licenses for health technologies needed to address COVID-1968.
Moreover, under article 31 bis of the TRIPS agreement, it is allowed to produce and export low cost generic medicines under a compulsory license “exclusively for the purpose of serving the needs of countries that cannot manufacture those products themselves69. It applies to pharmaceutical products (such as vaccines, drugs, medical material…) all needed to fight an epidemic. So here, it can be seen how IPRs can be a facilitator in the purchase of a new vaccine. A few solutions given by the doctrine will be discussed further.
Now that we briefly discussed the functioning of IPRs and how they can be challenging and at the same time helpful towards the production of a vaccine, it is time to discuss the EU Vaccine Strategy. In the following analysis, the main focus will be on how the EU Vaccine Strategy is balancing IPRs in order to accelerate the development and distribution of the vaccine.
66World Trade Organization, Ministerial Conference. Fourth Session, Doha 9-14 November 2001. “Declaration
on the TRIPS Agreement and Public Health”. Adopted on 14 November 2001. Parag 4. (URL: https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.pdf)
67 Report: The TRIPS Agreement and COVID-19. World Trade Organization. 15.10.2020.
(URL:https://www.wto.org/english/tratop_e/covid19_e/trips_report_e.pdf)
68 Ibid
69 WTO Analytical Index. Article 31bis of the Agreement on Trade-related aspects of Intellectual Property
22
V. EU Vaccine Strategy: the influence of IPRs.
IPRs international flexible mechanisms:
As already mentioned, IPRs are essential in the development of the vaccine. If the EU announced that the clinical trials will be accelerated, this requires that the researchers dispose of an extensive access of medical technologies, from scientific data, to protective equipment, to the latest analytical software, medicines, etc… The EU seems determined to reduce this timeline by maintaining higher safety health standards. As it has been already briefly mentioned, the EU could use article 31 and 31bis of the TRIPS Agreement as legal basis to allow every research institution to benefit from the latest resources available in order to speed up these clinical trials. Indeed, by allowing compulsory license without the authorization of its owner in the case of this global emergency; researchers will benefit from the latest data and medical technology available70. Moreover, the EU also addressed the market authorization problem in its strategy. They agreed on reducing the data available in order to approve marketing authorization as long as the vaccine’s benefits are greater than its risks.
Considering that the Pfizer vaccine is already in the EU market, in less than 12 months, it is reasonable to think that such mechanisms are potentially been used by scientists in order to accelerate the development of the vaccine.
This is a remarkable effort from international intellectual property law as usually, patent law offers this 20-year protection on biomedical inventions. Which is one of the main reasons why the development of a vaccine can take up to 10 years and usually even longer.
Concerning the fact that the EU can only legislate about IPRs “in light of the functioning of the internal market”, through its vaccine strategy, the EU showed they took into consideration other aspects than the internal market, such as social and political aspects, in order to face the crisis. Which means that from a legal point of view, it does not make sense to interpret IPRs only in the light of the functioning of the internal market and that this perspective needs to disappear in the context of IPRs. This contributed to the accelerated process of the development of the vaccine.
70Karavida, N. Onofrio, D, Merlen, D. “Patent Rights and Wrongs in the COVID-19 Pandemic: EU and U.S.
Approaches to Compulsory Licensing” IPWatchGod. 19.05.2020 (URL:
https://www.ipwatchdog.com/2020/05/19/patent-rights-wrongs-covid-19-pandemic-eu-u-s-approaches-compulsory-licensing/id=121709/)
23
Pull mechanisms:
The EU, in its EU Vaccine Strategy used pull mechanisms. Indeed, these APAs are needed to provide the supply of the vaccine. If push mechanisms are needed to fund the research, they however do not guarantee any positive result. Pull mechanisms at the contrary, rewards successful research and reduce the possibility of losing the investment. We can then see the urgency of the situation because in the case at hand, the EU already signed an APAs which is a pull mechanism without even the guarantee of a successful outcome… Recently, it has been seen that these APAs seem to be successful as the Commission approved the market authorization for the Pfizer vaccine.
In order to have a successful vaccine widely available, EU governments need to agree on IPRs now. This way they will prevent “bidding wars”71 between Member States and they can regulate the price as well in order to make sure the most vulnerable have access to the vaccine. This problem was addressed in the EU Vaccine Strategy, because with the Commission acting as the main negotiator, these bidding wars between Member States was prevented and at the same time the power of these companies was significantly reduced. So, through this legal tool, which are the APAs, the EU prevented this “bidding wars” that the current patent system would have created.
Open innovation
As mentioned above, the EU Vaccine Strategy is using flexible regulations in order to accelerate the creation of the vaccine. Some of these flexible regulations can be in conflict with existing regulations. IPRs could offer a possible solution to accelerate the development of the vaccine: for example, they could combine open innovation models and patent pools72.
A similar mechanism was mentioned in the EU Vaccine Strategy. Indeed, in its Strategy, and as already mentioned the EU created the ETF (Task Force) “to interact with developers of
71Y. Natsis. “Getting it right: COVID19 vaccines procurement” European Public Health Alliance. 30.06.2020.
(URL:https://epha.org/getting-it-right-covid19-vaccines-procurement/)
72 S. Scarpetta, M. Pearson, F. Colombo, E. Barrehno, G. Dedet, M. Wenzl. “Treatments and a vaccine for
COVID-19: The need for coordinating policies on R&D, manufacturing and access” OECD Policy Responses to Coronavirus (COVID-19). ( URL:
https://read.oecd-ilibrary.org/view/?ref=133_133372- v717pcul4c&title=Treatments-and-a-vaccine-for-COVID-19-the-need-for-coordinating-policies-on-RD-manufacturing-and-access)
24 COVID-19 vaccines and offer scientific support from the early stages of development.”73 This “open innovation” model used in patent law was already seen through the 2002-03 SARS case. In this case, it was the WTO which put together institutions working on the SARS research and encouraged the sharing of information between researchers, scientists. There, the scientific information was shared between these competitors and the sharing of these information outside the network was only possible after the institution which issued the information approved it74. Indeed, we can believe that this ETF has a similar functioning. The open innovation will stimulate scientific research as it would encourage research laboratories such as universities and businesses which are still in early stages of R&D to share their IPRs with the businesses which will invest in clinical trials and in the development of a potential vaccine and at the same time it will maintain and even encourage competition within these businesses which will use their exclusive IPRs75. The most important thing is to have a vaccine ready as soon as possible in order to save lives and businesses, by implementing this system, it would promote, encourage and accelerate technological progress, which increases the possibilities to have a successful vaccine faster and ultimately allows the health care systems to obtain an efficient vaccine and distribute to the population. At the same time, it would respect 17 (2) CFR as firms will maintain their exclusive IPRs while incentivizing the competition among firms.
The IPRs mechanisms mentioned above are potential regulations the EU used in patent law in order to accelerate the development of the vaccine. As already mentioned, patent law and IPRs are very much needed for the EU’s economy and innovation market. All these suggestions were mentioned in order to show that IPRs can actually facilitate the development of the vaccine and help the acceleration of its creation. By doing that, the other point this thesis intends to highlight, is that the actual IPRs system seems outdated, as flexible mechanisms have been used in order to allow the creation of the vaccine in less than 12 months. Ultimately, the creation and distribution of these vaccines, will save millions of lives and businesses. The current IPRs system in the biomedical sector should perhaps rethink its actual functioning, as in its current
73 Communication from the Commission to the European Parliament, the European Council, the Council and the
European Investment Bank EU Strategy for COVID-19 vaccines. COM/2020/245 final (URL: https://eurlex.europa.eu/legalcontent/EN/TXT/?qid=1597339415327&uri=CELEX:52020DC0245)
74Dr. Menon “Open innovation for Covid-19 crisis”. Innoget. 21.04.2020. (URL:
https://www.innoget.com/innovation-blog/news/149/open-innovation-for-covid-19-crisis)
75 Garrison, C. “Urgent collective action to meet the challenge of this pandemic crisis: a coronavirus related
intellectual property pool”. Medicines Law &Policy. 30.03.2020 (URL:
https://medicineslawandpolicy.org/2020/03/urgent-collective-action-to-meet-the-challenge-of-this-pandemic-crisis-a-coronavirus-related-intellectual-property-pool/)
25 form, they tend to strengthen the monopoly of big pharmaceutical companies and thus for a period of 20 years.
The following and last suggestion from the doctrine this paper will present, is a direct answer to how the current patent law system should be modified in the biomedical sector.
Reforming the patent system in biomedical products
Another solution would be to dismantle the patent system in the biomedical sector. This could be done at the EU level. Pr. Gubby argues for this. Patents allow a monopoly to certain companies, including in the medical sector. This means that pharmaceutical companies have the power to prioritize in which area they will invest to research but also to dictate the price of the medical supply. The risk of these monopolies is that for example they kill competition. Even though, one could argue that it incentivizes investments as without this protection, investors would not be able to secure their investment. However, Gubby sees biomedical inventions as vital to social welfare. Meaning that it is not appropriate that private companies have this control over medical knowledge, supply, and database. So, private companies should not regulate these inventions through the use of patent monopolies. Considering the current situation, it would not be disproportionate to agree with Hubby as the biomedical sector is what allow patients to benefit from new and more efficient treatments, which, ultimately safe lives. For this reason, biomedical patents, which fall under vaccine patents for COVID-19 research need to be “phased out” and replace by EU public funding scheme76. These massive public funds will trigger competition through research institutions while dismantling these monopolies, which will allow health systems to benefit from fairer access to biomedical material. This alternative, a priori, offers a faire balance between fundamental rights. Indeed, according to Gubby, these massive funds will trigger competition, which will respect article 16 CFR and also article 114 TFEU. Moreover, it would also kill the monopoly of big pharmaceutical companies which will lead to the increase of the market competition between research institutions: from laboratories, to start-ups. It is true that in the current EU Vaccine Strategy, these APAs strengthen the monopoly of certain big pharmaceutical companies, which, ultimately, harm the internal market.
Moreover, with this approach, the health and environmental will be more safeguard than ever, as the big companies will not regulate the market of biomedical products, but the EU will do
76H. Gubby. “Is the Patent System a Barrier to Inclusive Prosperity? The Biomedical Perspective” Wiley Online
26 so. As already mentioned, the EU needs to respect primary law, which means the biomedical products issued under EU law will respect articles 16, 35 and 37 CFR for example. The EU as the unique and main investor will guarantee that.
If this proposed solution can seem disproportionate and could harm the internal market, the current situation makes us think that an urgent reform is needed…
VI. Conclusion
Through the EU Vaccine Strategy, the EU showed that European cooperation was essential in order to tackle this global pandemic. Through legal mechanisms, such as these APAs, the EU secured millions of doses for all its Member States. The accelerated process of the development of the vaccine would not have been possible with the current EU legislation on IPRs. This thesis intends to provide a list of the flexible IPRs mechanisms the EU have potentially used to accelerate the development and distribution of the vaccine. From the share of data on the scientific research, to the market authorization, the EU is adapting its legislation to the current crisis. Thanks to this flexibility, the first vaccine against COVID-19 has been developed and authorized in less than 12 months. This makes us think that it seems proportionate to review the current patent law system in the biomedical sector as this 20 years protection on patents77 seem to be an obstacle to the fast development of vaccines, therefore, contributing to the deaths of millions of people and somehow, potentially violating article 35 of the CFR. After all, through the COVID-19 vaccine case, we have seen that the EU, acting as a public investor and using flexible regulations, obtained a vaccine and distributed it to the public in less than 12 months and thus saving millions of lives and also businesses.
Moreover, the EU, through these APAs managed to prevent bidding wars between Member States, most likely by including IPRs in these APAs. By acting as a public investor, the EU avoided the risk of monopoly, that patent law grants to big pharmaceutical companies and stimulated competition among different actors (the EU signed six APAs and is having exploratory talks).
27 To conclude, IPRs and more specifically, patent law in the biomedical sector, seem to be outdated as other alternatives have been used for the COVID-19 vaccine. The proposition of Pr. Gubby seems adequate in the case at hand, through these APAs, EU massive public funds are triggering the competition through research institutions while dismantling these monopolies, which is allowing health care systems to benefit from fairer access to biomedical material. This alternative, a priori, is the one which offers a fairer balance between fundamental rights. Indeed, the fact of getting the vaccine as soon as possible means article 35 CFR will be better applied by health care systems as hospital saturation will be under control thanks to the vaccine. This will also help to end the violation of article 16 CFR as due to the lockdowns all over Europe, multiple businesses had to be closed. If these violations can be justified by article 52 CFR, it is nevertheless important to find a balance as soon as possible. The availability of the vaccine is essential to find this balance and this balance has been found this fast partly thanks to these IPRs flexible mechanisms.
There is not enough data available to see what mechanisms have been used within EU’s legislation to accelerate scientific research. This thesis intends to provide a few possible IPRs which could have been used by the EU while also criticising the current patent law system in the biomedical sector. If the current IPRs system can be problematic in the development of the vaccine, this thesis also showed they are essential. In all cases, the current situation makes us think an urgent reform is needed and also possible.
The 6th January 2021, the EU approved the conditional market authorization of another vaccine, the Moderna vaccine78. Other approvals will follow in the following weeks…
78 Press Released from the official website of the European Medecine Agency: EMA recommends COVID-19
Vaccine Moderna for authorisation in the EU. (URL: https://www.ema.europa.eu/en/news/ema-recommends-covid-19-vaccine-moderna-authorisation-eu) 06.01.2021
28
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30 Hood, L. “Whoever invents a coronavirus vaccine will control the patent – and, importantly, who gets to use it.” The Conversation. May 2020. (URL: https://theconversation.com/whoever-invents-a-coronavirus-vaccine-will-control-the-patent-and-importantly-who-gets-to-use-it-138121).
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Natsis, Y. “Getting it right: COVID19 vaccines procurement” European Public Health Alliance. 30.06.2020. (URL:https://epha.org/getting-it-right-covid19-vaccines-procurement/)
Ren G. “European Parliament Members Urge Open Licensing For COVID-19 Products Financed Through EU Grants” Health Policy Watch. 27.03.2020 (URL: https://healthpolicy- watch.news/european-parliament-members-urge-open-licensing-for-covid-19-products-financed-through-eu-grants/)
Salazar, S. “Intellectual Property and the Right to Health” WIPO (URL: https://www.wipo.int/edocs/mdocs/tk/en/wipo_unhchr_ip_pnl_98/wipo_unhchr_ip_pnl_98_3.pdf Scarpetta, S. Pearson, M. Colombo, F. and Guanais F. “Beyond containment: Health systems responses to COVID-19 in the OECD,” Organisation for Economic Co-operation and Development, updated April 16, 2020, oecd.org. (URL: https://read.oecd-ilibrary.org/view/?ref=119_119689-ud5comtf84&title=Beyond_Containment:Health_systems_responses_to_COVID-19_in_the_OECD) Scarpetta, S. Pearson, M. Colombo, F. Barrehno, E. Dedet, G and Wenzl, M. “Treatments and a vaccine for COVID-19: The need for coordinating policies on R&D, manufacturing and access” OECD Policy Responses to Coronavirus (COVID-19). (URL: https://www.oecd.org/coronavirus/policy-
responses/treatments-and-a-vaccine-for-covid-19-the-need-for-coordinating-policies-on-r-d-manufacturing-and-access-6e7669a9/#endnotea0z23)
Books and articles:
Ferrarro, F. and Carmona, J. “Fundamental Rights in the European Union: The role of the Charter after the Lisbon Treaty” European Parliamentary Research Service. March 2015 (URL: https://www.europarl.europa.eu/RegData/etudes/IDAN/2015/554168/EPRS_IDA(2015)554168_EN.p df)
