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The Conditional Marketing Authorisation of Covid-19 Vaccines: A Critical Assessment under EU Law

In: European Journal of Health Law
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  • 1 Department of Law, University of Luxembourg, 2 Avenue de l’Université, L-4365 Esch-sur-Alzette, Luxembourg
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Abstract

The decision of the EU Commission, based on positive advice from the European Medicines Agency, to grant conditional marketing authorisation to Covid-19 vaccines should be qualified as a precautionary measure. Under the established case law of the CJEU, the conditions for the application of this principle are met. Such conditions are the existence of a risk to the environment and public health and uncertainty. Given this qualification as a precautionary measure, whether the Commission had complied with the procedural obligations that surround the implementation of this principle under EU law was assessed. Some shortcomings are identified concerning the risk assessment conducted by the European Medicines Agency and the risk management carried out by the Commission.

Abstract

The decision of the EU Commission, based on positive advice from the European Medicines Agency, to grant conditional marketing authorisation to Covid-19 vaccines should be qualified as a precautionary measure. Under the established case law of the CJEU, the conditions for the application of this principle are met. Such conditions are the existence of a risk to the environment and public health and uncertainty. Given this qualification as a precautionary measure, whether the Commission had complied with the procedural obligations that surround the implementation of this principle under EU law was assessed. Some shortcomings are identified concerning the risk assessment conducted by the European Medicines Agency and the risk management carried out by the Commission.

If you do not take change by the hand, it will take you by the throat

Winston Churchill

1 Introduction

This paper does not contain any value judgement on the efficacy of the Covid-19 vaccination, nor should it be interpreted as intending to discredit the important role played by the producers of vaccines, the European Medicine Agency (EMA) and the European Commission in the vaccination campaign. Focusing only on an assessment of the legal implications of the decision of the Commission to grant conditional marketing authorisation (CMA) to Covid-19 vaccines, its purpose is to nurture the legal discussion of the conditions and effects of public health measures taken in an atmosphere of risk and uncertainty. It applies the legislation, case law and scholarship on the precautionary principle to evaluate the granting of CMA to Covid-19 vaccines.

The race towards a Covid-19 vaccine profoundly marked 2020 and 2021 during which a global planetary effort was devoted to the research, production, authorisation and distribution of vaccines. Europe played a primary role in securing vaccines for European citizens and facilitating their distribution. According to the EU Vaccination Strategy1 jointly adopted by the EU Institutions and Member States to support companies in the swift development and production of a vaccine, the EU Commission entered into agreements with individual vaccine producers on behalf of Member States. In return for the right to buy a specified number of vaccine doses, the Commission financed part of the upfront costs of the producers. This took the form of advance purchase agreements. Funding for the procurement of vaccines was provided mainly through the Emergency Support Instrument, a form of pooled EU funding made available by the Commission in an emergency, and was considered as a down payment on the vaccines that were purchased by the Member states.2 As a result of this common strategy, on 7 January 2022, 1.2 billion doses of vaccine had been delivered and 80% of the EU adult population was fully vaccinated.3

If the EU institutions and Member states were able in a few months to secure access to vaccines for a large portion of the EU population, this was not without assuming any risks. According to the Commission, ‘the quest for a vaccine against Covid-19 is particularly challenging due to the urgency’.4 The urgency in the production of Covid-19 vaccines raised significant doubts from the scientific perspective as to their quality, safety and efficacy5 and gave rise to sometimes remarkable protest by a portion of the civil society worried by the quick and widespread distribution of the vaccines among the population.6 There were also legal concerns. The decision by the EU to impose a vaccine passport (EU Digital Covid Certificate) to facilitate the free movement of people in Europe has been analysed by legal scholars7 by considering, inter alia, its implications in light of fundamental principles8 and data protection.9 However, little attention has been paid to the decision of the Commission, acting on the positive advice of the EMA, to grant a CMA to some Covid-19 vaccines. Yet, the analysis of this decision is of the utmost importance to assessing the legality of the authorisation of Covid-19 vaccines in the EU.

This article analyses the decision of the Commission to grant a CMA. The core claim of this paper is that the decision of the Commission should be qualified as a precautionary measure. Indeed, according to the established case law of the CJEU, the conditions for the application of this principle are met.10 We are facing a serious risk to public health linked both to the continuous spread of Covid-19 and the large-scale use of new vaccines, which still need to prove their efficacy to contain the diffusion of the virus, especially in the long term. However, this risk is uncertain since the scientific data supporting the authorisation of vaccines are incomplete and require further investigation. In these circumstances of risk and uncertainty, the precautionary principle should apply. Provided for by Article 191 para. 2 of the Treaty on the Functioning of the European Union (TFUE), the precautionary principle is a key principle of the European environmental policy. Since National Farmers’ Union and the United Kingdom v. Commission in 1998,11 the CJEU has repeatedly applied the precautionary principle in the field of public health.12 As a principle of anticipated action, precaution requests the decision-makers to anticipate the time of action when there is an uncertain risk affecting the environment and public health.13 Therefore, if traditionally public action was conditional on the proof of a certain risk, the precautionary principle obliges the authorities to anticipate the time of action at the stage of uncertainty.

As a precautionary measure, the legality of the decision of the Commission should be assessed accordingly and decision-makers (EU institutions and Member states) enjoy a wide discretionary power because of the complexity of the issues before them. As stated by Advocate General J. Mischo in Commission of the European Communities v. the Kingdom of Denmark, ‘the greater the scientific uncertainty, the greater the margin of appreciation of the authority’.14 Since the available scientific data do not support decision-making with certainty and the existence or extent of the risk remains uncertain, it is for decision-makers in the exercise of their discretion to decide whether and how to implement a precautionary measure. Therefore, the choice of the response is the result of a discretionary decision based on the level of risk deemed acceptable by the authorities. However, the discretionary power of the decision-makers is not unlimited because they must comply with a set of procedural obligations aimed at ensuring that even under scientific uncertainty, the use of the precautionary principle is backed by scientific data and it is not arbitrary.15 As the General Court points out, compliance with the procedural obligations ‘constitutes the primary raison d’être of the precautionary principle’.16

This paper assesses the decision to grant a CMA and the application of a precautionary measure and whether the Commission has complied with its obligations surrounding the implementation of the precautionary principle under EU law. The key issue is the balance between the need to speed up the authorisation procedure to quickly deploy the vaccines and the obligation to ensure their quality, safety and efficacy under EU law.

The paper is structured as follows. After this introduction, Section 2 examines the standard procedure for the authorisation of vaccines and Section 3 the accelerated procedure for the authorisation of Covid-19 vaccines. The decision itself is examined in Section 4 and Section 5 concludes the paper.

2 The Standard Procedure for the Authorisation of Vaccines

Standard vaccine development is a long process that involves several sequential steps. Companies first make small batches of the vaccine and carry out small-scale studies to determine a suitable formulation that can keep the vaccine’s components stable to the end of its shelf life. Then the company decides whether to continue development and scale-up production. To assure that the vaccine meets its intended quality profile and complies with regulatory standards, the company develops a quality control strategy. Studies on pharmaceutical quality look at the individual vaccine components, the final formulation to be used and at the whole manufacturing process in detail. Then the vaccine developer conducts more studies in laboratory models, using in vitro studies or animal models in vivo studies, to show how the vaccine triggers an immune response and works to prevent or mitigate infection. Finally, the developer studies the vaccine in three phases of clinical trials, with larger numbers of volunteers in each phase. Once the clinical trials have been completed, the developer can ask for authorisation for the vaccine.17 According to available data, the development of vaccines normally takes between five and fifteen years.18

In the EU under Directive 2001/83/EC19 and Regulation 726/2004,20 a medicinal product for human use may be authorised either by the EU Commission after positive advice from the EMA through a centralised procedure or by competent national authorities under national procedures. The centralised procedure is compulsory for human medicines containing a new active substance to treat human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS), cancer, diabetes, neurodegenerative diseases, auto-immune and other immune dysfunctions and viral diseases.21 As a result, while the majority of new, innovative medicines, including vaccines, are subject to the centralised authorisation procedure, most generic medicines are assessed and authorised at the national level.

Under the centralised procedure, any vaccine developer that wishes to put a vaccine on the EU market should submit a single marketing authorisation application to the EMA which details the safety, efficacy and quality of the vaccine. The EMA’s evaluation procedure involves specialised Committees. First, the Pharmacovigilance Risk Assessment Committee assesses the safety of the vaccine. Then, the Biologics Working Party verifies its quality. Eventually, the EMA’s Committee on Human Medicines (CHMP) – which includes members from all Member states – issues the final recommendation to the EU Commission if the evidence shows that the benefits of vaccination are greater than any risks from the vaccine. The opinion of the CHMP is given within 210 days of the receipt of a valid application.22 Following a positive recommendation from the CHMP, the Commission verifies the soundness of all elements supporting the marketing authorisation. These include scientific justifications, product information, educational material to health care professionals, labelling, and conditions for the use of the vaccine. Before authorising the vaccine, the Commission, through the comitology process, consults Member states which are responsible for the domestic marketing and use of the vaccine. Once granted, the CMA is valid in all Member states. After a vaccine has been authorised for use, the EMA and Member states monitor its safety and act if new information indicates that it is no longer as safe and effective as previously assessed.

3 The Accelerated Procedure for the Authorisation of Covid-19 Vaccines

Due to the emergency and the need to quickly find something to inhibit the spread of Covid-19, the development and the authorisation procedure of Covid-19 vaccines have been accelerated.

Following massive investment in resources, the manufacturers were able to analyse results from earlier studies more quickly and simultaneously and map out the next steps for resources, funding and regulatory strategy. They expanded manufacturing capacity and were able to begin large-scale production immediately after approval was given. The greatest gain in acceleration of the production process was possible because of the contraction of the standard procedure for the development of vaccines and the combination of different phases of their development. Clinical trials started before the completion of the in vitro and in vivo tests and the EMA began to evaluate the vaccine before the standard laboratory checks had been completed. Some manufacturers started producing their vaccines before obtaining EU marketing authorisation. As a result, vaccines were distributed across the EU and available for use before the standard procedure for their development was complete.

Regarding the authorisation procedure, several arrangements allowed for a faster decision by the EU Commission that allowed for the authorisation of the first vaccine (Comirnaty developed by BioNTech and Pfizer) only 9 months after the pandemic was declared.

First, under Article 14(7) of Regulation 726/2004 and the provisions of Regulation 507/2006,23 the Commission and Member states agreed to activate the CMA procedure to expedite the approval of Covid-19 vaccines. This is in line with the provisions of Article 21 of Regulation 1234/2008 that, in a pandemic, enables the Commission to exceptionally and temporarily accept a variation to the terms of a marketing authorisation for a human influenza vaccine, where some non-clinical or clinical data are missing. Under the framework of the CMA, a marketing authorisation is granted on less comprehensive clinical data than normally required, where the benefit of immediate availability of the medicine outweighs the risk inherent in the fact that additional data are still required. The CMA is used as a fast-track authorisation during public health emergencies to speed up approval and save lives. Under Article 4 of Regulation 507/2006, a CMA may be obtained where the EMA’s Committee on Human Medicines finds that, although comprehensive clinical data referring to the safety and efficacy of the medicinal product have not been supplied, all the following requirements are met:

  • (a) the risk-benefit balance of the medicinal products is positive;

  • (b) it is likely that the applicant will be able to provide the comprehensive clinical data;

  • (c) the medicine will allow fulfilling unmet medical needs; and

  • (d) the benefit to public health of the immediate availability on the market of the medicinal product concerned outweighs the risk inherent in the fact that additional data are still required.

CMA are valid for one year and can be renewed annually. Once a CMA has been granted, the marketing authorisation holder must fulfil specific obligations within defined timelines. These include completing ongoing or new studies and collecting additional data to confirm that the medicine’s benefit-risk balance remains positive. The CMA can be converted into a standard marketing authorisation (no longer subject to specific obligations) once the holder fulfils the obligations imposed and the complete data confirm that the medicine’s benefits continue to outweigh its risks.

Second, to support the granting of a CMA, the EMA conducted a rolling review of scientific data provided by vaccine developers. This allowed the EMA to evaluate the quality, efficacy and safety of the vaccines continuously as data become available instead of waiting until all the trials were completed. This significantly shortened the normal assessment time. During the review, a Covid-19 EMA pandemic task force (Covid-Etf) was established to support EMA and its scientific committees. It brought together experts from across the European medicines regulatory network to advise on the development, authorisation and safety monitoring of vaccines and facilitate quick and coordinated regulatory action.24

Third, the EU Commission also ensured that the process leading to vaccines’ marketing authorisation took place as quickly as possible by shortening administrative steps, such as the period for consulting the Member states through comitology and by allowing translation of all the relevant documents into the full set of languages after the granting of the authorisation, rather than before. While the average standard process for the authorisation of medicinal products takes 67 days, including 22 for the consultation of Member states, as for Covid-19 vaccines, the Commission was able to proceed with a marketing authorisation within 3 days following a positive recommendation from EMA.

Fourth, in July 2020, the EU Parliament and the Council adopted Regulation 2020/104325 concerning Covid-19 vaccines as some of them may be classified as genetically modified organisms (GMOs). Under Article 2, all operations related to the conduct of clinical trials of Covid-19 vaccines containing or consisting of GMOs shall not require a prior environmental risk assessment or the consent of national authorities in derogation of Articles 6 to 11 of Directive 2001/18/EC and Articles 4 to 13 of Directive 2009/41/EC (the ‘GMOs Directives’). Producers of the vaccine were to implement measures to minimise any environmental impact resulting from the intended or unintended release of the GMOs into the environment, and the manufacture of the vaccine was to be subject to the terms of the GMOs Directives. The Regulation will remain in place until Covid-19 is considered as a pandemic. Its purpose is to facilitate production and reduce the time taken to execute the clinical trials. Under the GMOs Directives, an environmental risk assessment was a precondition for consent to carry out clinical trials involving GMOs. However, there is considerable variation between Member states in the requirements for evaluation of the environmental risks for such trials. If all these requirements had to be respected in all Member states where clinical trials were to be implemented, this would have caused enormous delays in the deployment of the vaccines.

4 The Conditional Marketing Authorisation of Covid-19 Vaccines and the Precautionary Principle

To assess in light of the precautionary principle the legality of the decision of the Commission to grant a CMA to Covid-19 vaccines, it is first necessary to assess whether the conditions for the application were met. These are the existence of risk and uncertainty.

First, concerning the risk, the CJEU has ruled that the precautionary principle is to be applied without having to wait until the reality and seriousness of the risk are fully demonstrated by scientific data.26 Consequently, the risk has two main features: from a scientific and objective point of view, it is real, and from the social and subjective perspective, it is serious. An objective risk can be identified quantitatively by applying a scientific calculation to measure the probability of its occurrence.27 Because it is a mathematical probability, the risk can be evaluated in an impersonal manner. The evaluation is made by scientific experts using scientific documents, studies and parameters. However, risk cannot be separated from the lives of people. According to the German sociologist Ulrich Beck, either we consider that any man independent of his money, class, profession or accommodation is equally exposed to the risks or we are obliged to reformulate the traditional thoughts on the nature of risks to affirm that the risk evolves according to the changes lived by its recipients.28 Thus, the risk has a subjective nature. The perception of risks is not fixed and absolute, but depends on the personal features and state of mind of the people called on to appreciate its existence. Under EU law, the political decision-makers ascertain the appreciation of uncertain risk. This appreciation is critical; only uncertain risks which are considered sufficiently severe justify the anticipation of the time of action based on the precautionary principle.

In the case of Covid-19, the risk is both real and serious. As to its reality, since the outbreak of the pandemic, experts played a primary role in assessing the negative consequences of Covid-19 in terms of an increased level of mortality and morbidity in the population and produced an extensive amount of data to quantify the probability of occurrence and the conditions of spreading of the virus.29 The risk connected to the deployment of new vaccines is also real. The development and authorisation of Covid-19 vaccines are subject to the scientific proof that, despite the quick research and production process, the risk-benefit balance of the vaccine is still positive and the benefit to public health of its immediate availability outweighs the risk inherent in the fact that additional data are still required. With regard to its seriousness, there is a widespread acknowledgement that this pandemic is the worst public health emergency of international concern that modern society has faced.30 The enormous economic, political and social consequences of Covid-19 not only defined the scope of the emergency measures adopted in the last two years at the EU level31 but will also shape the action taken to ensure a smooth post-pandemic European governance.

Second, uncertainty results from a limitation of scientific knowledge that experts have when the scientific evaluation of the risk is carried out. This means that the available scientific data are not enough to infer with certainty the existence or extent of risk. The lack of information might be quantitative or qualitative. From a quantitative perspective, scientific knowledge is lacking if available data are not enough to let the experts establish without any doubt that the risk will occur.32 Scientific knowledge may also be lacking from a qualitative perspective because the available data may be ambiguous, inconclusive or contradictory.33

In the case of Covid-19, the risk is uncertain both from the quantitative and the qualitative point of view. Not only are scientific data still lacking, but they are also subject to divergent interpretations and remain somehow ambiguous, inconclusive and contradictory as to the assessment of the effects on human health of the viral infection.34 The same uncertainties apply concerning the use of Covid-19 vaccines, hence the requirement for the developers to publish new scientific information as soon as it is available.

In these circumstances of risk and uncertainty, the precautionary principle should apply. One might argue that the decision of the Commission to grant a CMA cannot qualify as a precautionary measure because the term ‘precaution’ was not employed. However, the CJEU has held that the lack of labelling of a decision as a precautionary measure does not preclude its qualification as such if the conditions for the application of the principle are met.35 Indeed, the proceeding of qualification is often hidden and results implicitly from the establishment of a correlation between a factual element and its legal consequences.36 Therefore, for the precautionary principle to apply it is necessary to assess whether its conditions for application are met rather than verifying if the EU institutions and Member states employed the term to qualify a measure that they adopted.

The legality of the decision by the Commission to grant a CMA is subject to compliance with the procedural obligations surrounding the wide discretionary power granted to EU institutions and Member states for the implementation of the precautionary principle. These obligations concern both the risk assessment conducted by scientific experts before the implementation of a precautionary measure and the risk management by political decision-makers based on the findings of the scientific assessment.37

To assess the legality of the decision of the Commission to grant a CMA to Covid-19 vaccines, I will examine whether these procedural obligations were complied with.

4.1 The Risk Assessment of Covid-19 Vaccines

Risk assessment is usually a four-step procedure that includes: (1) hazard identification – does the substance give rise to an adverse effect; (2) dose-response, which determines how potent it is; (3) exposure assessment which determines who or what might become exposed; and (4) risk characterisation which looks at the likelihood of harm following exposure.38 For decision-makers to apply the precautionary principle by anticipating the time of action, experts must evaluate the uncertain risk at stake. Only uncertain risks properly assessed justify the anticipation of the action based on the precautionary principle.

According to established case law, the risk assessment must be based on the best and most reliable scientific data,39 and the most recent results of international research.40 The CJEU does not specify the meaning to be attributed to these terms, nor does it indicate which types of studies meet these criteria. However, by granting the experts the discretion to choose the scientific sources of their expertise, the Court stresses the importance of selecting the highest quality data. This was echoed by Advocate General Poiares Maduro in Commission v. the Netherlands in which he underlined the importance of high-quality expertise to decision-makers.41 The risk assessment must also be transparent42 and carried out by independent experts separated from the political decision-makers43 and who do not have a conflict of interests with third parties potentially affected by their decision.44

The analysis of this discharge of this obligation, in this case, raises several concerns. These are, of course, only preliminary concerns that will be reassessed in the coming months as further details emerge.

First, one may wonder if the decision by the EMA to implement a rolling review of the scientific data is compatible with the idea of grounding the risk assessment with the best scientific data, or simply the most available data. The question arises since the rolling review is an ad hoc procedure that can be activated by EMA in an emergency to speed up the risk evaluation by assessing the data for an upcoming highly promising application as they become available, but preceding the formal submission of a complete application for marketing authorisation.45 Therefore, by definition, the scientific information submitted has not been selected to identify the best, but rather is all that is available when the application is filed. To compensate for the lack of quality that a rolling review might cause, its use is subject to the specific agreement of the Covid-Etf task force. It is also limited to products that are of strategic importance in the pandemic and for which the dossier and manufacturing plans are sufficiently mature that the application for a CMA can be expected within 4 months of the start of the rolling review.46 Even with these limitations, the question remains as to the compatibility of the rolling review with the principle of excellence that should govern the risk regulation of precautionary measures.

Second, if the EMA stressed its strong commitment to ensuring the transparency of its evaluation procedure of Covid-19 vaccines by shortening its standard publishing timeframes and publishing information it does not normally publish for other medicines,47 it is more difficult to assess its compliance with its obligation to ensure independent expertise. Following an inquiry of the European Ombudsman,48 the EMA took measures to ensure separation between the experts involved in providing advice on the development of Covid-19 vaccines and those in charge of their evaluation. It is also true that when establishing the mandate, objectives and rules of procedure of the Covid-Etf that played a key role in the evaluation of Covid-19 vaccines, the EMA clearly stated that the members of the committee:

shall not have any direct interests in the pharmaceutical industry, which could affect their impartiality. They shall undertake to act in the public interest and an independent manner and shall make a declaration of their financial and other interests at least on an annual basis or when new interests arise […] Members of the Covid-Etf and experts shall refrain from involvement in any purchase procedure under the EU Advance Purchasing Agreement for Covid-19 vaccines. If involved in such purchase procedure, restrictions on involvement in ETF activities are applicable to Covid-Etf and experts.49

However, to ensure the independence of that expertise, it will be necessary over the coming months to assess whether the EMA has been able to avoid interference with vaccine developers that might have jeopardised that independence. If this aspect is particularly difficult to check under normal circumstances, it will be even more challenging for Covid-19 vaccines. Not only the urgency of the authorisation procedure but also the necessary dialogue and exchanges with private companies applying for Covid-19 vaccines that characterised the EMA’s risk assessment are all elements that will require a further investigation to assess the compliance with the principle of independence of the expertise.

Third, the adoption of Regulation 2020/1043 derogating for the duration of the pandemic the requirement for an environmental risk assessment as a condition for obtaining consent for clinical trials raises a question of compatibility with the precautionary principle. The application of this principle is conditional on the execution of a risk assessment as complete and exhaustive as possible.50 The purpose of this assessment is to confirm that, despite the existence of scientific uncertainty, the risk is sufficiently grounded and is not hypothetical.51 Considering the obligation to execute a risk assessment before implementing the precautionary principle, the decision to lift this obligation for clinical trials of the vaccines containing GMOs might cause some surprise. This measure is justified by the objective of protecting public health ‘in the unprecedented situation of public health emergency created by the Covid-19 pandemic’52 and the need to quickly approve the vaccines by avoiding the bureaucracy linked to the environmental risk assessment before the clinical trials. Against this backdrop, the EU legislator considers that the protection of public health ensured by the development of vaccines shall prevail for the time of the pandemic over the environmental and public health risks that may originate from the release into the environment of GMOs.53 If no other indications are given on the modalities for the carrying out of this balance of interests, the Regulation limits the scope of the derogation by providing that the producers of the vaccine shall implement measures to minimise any environmental impact resulting from the intended or unintended release of GMOs into the environment, and the manufacture of the vaccine shall still be subject to the terms of the GMOs Directives.

In light of the above, it is worth considering that if the need to protect public health by rapidly deploying vaccines is undeniable and the EU institutions enjoy a wide discretionary power to exercise on a case-by-case basis a balance of interests, it is also important to guarantee the legality of the authorisation of vaccines in compliance with the precautionary principle. A risk assessment is a guarantee of the sound use of the precautionary principle and a limitation to the discretionary power of the authorities. It is indeed intended to avoid arbitrary measures that are not backed up by scientific evidence. The assessment is particularly relevant in cases of scientific uncertainty as to the effects on the environment and public health, and it is of the utmost importance for clinical trials of products containing GMOs. The clinical trials are meant to investigate the clinical, pharmacological and other pharmacodynamic effects of the products to determine their safety and efficacy.54 It is during these trials that adverse effects on human health or the environment will be revealed. Hence the GMOs Directives make release into the environment (Directive 2001/1855 ), and the contained use of any product composed of GMOs (2009/41/EC56 ) conditional on the execution of a risk assessment. Can the urgency to dispose of Covid-19 vaccines allow for a bulk derogation to the system of protection built by the GMOs Directives to limit the risks associated with the release into the environment and use of GMOs during the performance of clinical trials? This was the position defended by the EU institution with the adoption of Regulation 2020/1043. However, more systematic reading of this Regulation based on the norms governing the application of the precautionary principle and the need to limit the discretionary power of the authorities raise some doubts as to the legitimacy of the derogation to the obligation to execute an environmental risk assessment.

4.2 The Risk Management of Covid-19 Vaccines

Risk management is the political process involving risk evaluation, options assessment, option implementation, monitoring and review to achieve an appropriate level of protection.57 The risk management of the precautionary measures by EU political decision-makers involves two procedural obligations.

First, the decision-makers must consider the results of the risk assessment conducted by the EMA. This obligation gives rise to a duty of care. They must examine, carefully and impartially, the scientific assessment made by experts before the adoption of a precautionary measure to show that, although uncertain, the risk is sufficiently likely to require the implementation of a protective measure.58 They must also consider any new scientific knowledge arising after the expert assessment was carried out which could change the evaluation. According to the CJEU in French Republic v. Commission59 and by the General Court in Solvay Pharmaceuticals v. Council,60 the production of new scientific knowledge may require a re-examination of the measure taken under the precautionary principle. Therefore, when new elements change the perception of risk or show that it can be limited by less restrictive measures than those already in place, it is up to the authorities to ensure that the measures taken are adapted to the new scientific data.

Second, decision-makers must consider the other pros and cons of the action. In Bayer Crop v. European Commission,61 the General Court explicitly recognised the binding nature of the pros and cons analysis and the obligation on decision-makers to carry it out before adopting a precautionary measure. However, the Court did not specify how it should be done, which leaves decision-makers with a wide margin of discretion.62 For the Commission, this analysis is generally carried out with the implementation of a cost and benefit analysis.63 The obligation to analyse the costs and benefits of the action responds to the need to broaden the spectrum of elements considered before the adoption of a precautionary measure to include non-scientific considerations.

The risk management by the Commission before granting a CMA raises several concerns. Again, these are only preliminary and will need to be reassessed in the coming months.

First, considering the lack of comprehensive scientific data that supported the granting of the CMA, it is important to verify compliance with the obligation to consider new scientific evidence that might have emerged after the granting of the CMA. This will be possible with the implementation of an efficient monitoring system. This is important because exceptionally large numbers of people received Covid-19 vaccines, many more than the large numbers involved in the clinical trials. Therefore, it is only after the authorisation that the quality, safety and efficacy of Covid-19 vaccines will be tested on a significant scale and under real-life use. The manufacturers have been entrusted by the framework of the CMA to provide the EMA and the Commission with the results from the main trials of the vaccines, which are ongoing. These trials and the additional studies conducted by vaccines developers will provide further information on the quality, safety and efficacy of the vaccines. The EMA and the national authorities have also prepared a safety monitoring plan for the vaccines64 which outlines how relevant new information emerging after the authorisation and uptake of the vaccines will be collected and reviewed. The plan requires the EMA to monitor suspected side effects reported by individuals and healthcare professionals posted to an EU database called EudraVigilance.

The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) continuously monitors EudraVigilance to identify any new safety issues. These are known as safety signals. When assessing a safety signal, it looks for any unusual or unexpected patterns such as a medical event occurring in vaccinated people at a higher rate than in the general population. It then conducts a robust assessment of all the combined safety data before concluding how the signal affects the vaccine’s safety and its benefit-risk balance. If needed, the EMA may decide to update the vaccine’s product information to provide revised advice to healthcare professionals and patients, require the manufacturer to conduct additional studies, or restrict the use of the vaccine.65 To comply with its duty to consider any new scientific information that might change the appreciation of the risk and uncertainty, the Commission must consider evidence from the monitoring of Covid-19 vaccines and, if necessary, modify or withdraw their CMA.

Second, one might wonder if the need to speed up the authorisation of Covid-19 vaccines fully justifies the decision of the Commission to reduce the consultation period of the Member states through the comitology procedure.66 This procedure is important in ensuring that, besides the scientific findings, the precautionary measure is grounded by the consideration of other non-scientific factors such as the social, economic or political implications. This is even more important in CMA construct. If the dialogue with the regulatory authorities of the Member states has been performed by the Covid-Etf task force, it is not unreasonable to expect it would happen again at the risk management stage. Given that the decision to grant a CMA had enormous consequences in the social, political and economic arenas, it was important to be sure that the effect of these non-scientific factors was properly considered.

5 Conclusion

‘In the biggest global health crisis for a century, we chose to go it together so that every part of Europe got the same access to a life-saving vaccine’.67 With these words, taken from the 2021 speech on the State of the Union, the President of the EU Commission, Ursula Von der Leyen highlighted the significant efforts made by the EU institutions and Member states to ensure access to Covid-19 vaccines for the European population. However, as she recognised, ‘the speed of events and the enormity of the challenges are sometimes difficult to grasp’.68 One of the biggest challenges lies in the trade-off between the need to quickly deliver vaccines by speeding up their development and authorisation and the obligation to ensure their quality, safety and efficacy in compliance with EU law. As a response to this trade-off, the EU Commission granted – on positive advice from the EMA – a CMA to those Covid-19 vaccines that meet the criteria set out by the applicable regulations.

Against this backdrop, the core claim of this paper is that the decision of the Commission should be qualified as a precautionary measure. According to the established case law of the CJEU, the conditions for the application of this principle have been met. These are the existence of a risk to the environment and public health and uncertainty.69 With the qualification of the decision of the Commission as a precautionary measure, its legality was assessed to determine if the Commission had complied with the procedural obligations that surround the implementation of the precautionary principle under EU law. As a result of this analysis, some issues have been identified concerning the risk assessment conducted by the EMA and the risk management by the Commission. This analysis does not contain any value judgement on the opportunity or efficacy of the Covid-19 vaccination. By pointing out and assessing some elements of concern of the CMA under the precautionary principle, the paper offers a reflection on the conditions and effects of public health measures taken in a condition of risk and uncertainty. This might be relevant given the current revision of the health regulations being undertaken by the EU institutions70 to better reconcile the need to act quickly in an emergency with the obligation to comply with the procedural requirements of the precautionary principle under EU law.

1

EU Commission, 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.

2

For more info on the Emergency Support Instrument, see Emergency Support Instrument (2021), available online at https://ec.europa.eu/info/live-work-travel-eu/coronavirus-response/emergency-support-instrument_en (accessed 15 October 2021).

3

EU Commission, Safe COVID-19 vaccines for Europeans (2021), available online at https://ec.europa.eu/info/live-work-travel-eu/coronavirus-response/safe-covid-19-vaccines-europeans_en (accessed 7 January 2022).

4

Supra note 1, p. 1.

5

The Conversation, ‘A researcher’s view on COVID-19 vaccine hesitancy: The scientific process needs to be better explained’, The Conversation (16 September 2021), available online at https://theconversation.com/a-researchers-view-on-covid-19-vaccine-hesitancy-the-scientific-process-needs-to-be-better-explained-167681 (accessed 15 October 2021); Science Daily, ‘Coronavirus vaccines stir doubts among many people worldwide, new study shows’, Science Daily (20 October 2020), available online at https://www.sciencedaily.com/releases/2020/10/201020131340.htm (accessed 15 October 2021).

6

CGTN, ‘Anti-vaccination protests in London, Paris and Zagreb: COVID-19 Daily Bulletin’, CGTN (19 September 2021), available online at https://newseu.cgtn.com/news/2021-09-19/Anti-vaccine-protests-in-London-Paris-and-Zagreb-COVID-19-Bulletin-13GqUK5m51e/index.html (accessed 15 October 2021). Moreover, for Italy, see: Reuters, ‘Anti-vax protesters in Rome target Draghi’s office, union’s headquarters’, Reuters (9 October 2021), available online at https://www.reuters.com/world/europe/italian-police-use-water-cannon-push-back-anti-vax-protesters-rome-2021-10-09/ (accessed 15 October 2021).

7

See, for example, the Symposium organised by the EJRR in June 2021 on ‘COVID-19 Certificates’, available online at https://www.cambridge.org/core/journals/european-journal-of-risk-regulation/latest-issue.

8

A. Alemanno and L. Bialasiewicz ‘Certifying Health: The Unequal Legal Geographies of COVID-19 Certificates’, European Journal of Risk Regulation 12(2) (2021) 273–286; E. Paris, ‘Applying the Proportionality Principle to COVID-19 Certificates’, European Journal of Risk Regulation 12(2) (2021) 287–297; T. Luster, E. Albin, A. Gross, M. Tabenkin and N. Davidovitch, ‘Promoting Vaccination from a Human Rights and Equity Perspective: Lessons from the Israeli “Green Pass”’, European Journal of Risk Regulation 12(2) (2021) 308–320.

9

O. Gstrein, ‘The EU Digital COVID Certificate: A Preliminary Data Protection Impact Assessment. European Journal of Risk Regulation’, European Journal of Risk Regulation 12(2) (2021) 370–381.

10

See, inter alia, CJEU 5 May 1998, National Farmers’ Union and others, C-157/96, EU: C:1998:191; CJEU 5 May 1998, United Kingdom v. European Commission, C-180/96, EU: C:1998:192; CJCE 23 sept. 2003, European Commission v. Kingdom of Denmark, C-192/01, ECLI:EU:C:2003:492; GC 11 September 2002, Pfizer Animal Health v. Council, T-13/99, EU:T:2002:209; GC 17 May 2018, Bayer CropScience AG v. European Commission, T-429/13 and T-451/13, ECLI:EU:T:2018:280.

11

CJEU 5 May 1998, National Farmers Union, supra note 11, EU:C:1998:191; CJEU 5 May 1998, United-Kingdom v. Commission, C-180/96, supra note 10.

12

CJEU 26 May 2005, Codacons and Federconsumatori, C-132/03, EU:C:2005:310; CJEU 12 January 2006, Agrarproduktion Staebelow, C-504/04, EU:C:2006:30; GC 10 March 2004, Malagutti-Vezinhet, T-177/02, EU:T:2004:72; GC 7 March 2010, Acino v. Commission, T-539/ 10, EU:T:2013:110.

13

On the definition of the precautionary principle as a principle of anticipated action, see A. Donati, Le principe de precaution en droit de l’Union européenne, (Brussels: Bruylant, 2021).

14

Conclusions of the Advocate General J. Mischo, CJEU 23 September 2003, European Commission v. Kingdom of Denmark, C-192/01, EU:C:2002:760, para. 103.

15

Donati, supra note 13, p. 191.

16

GC, 11 September 2002, Pfizer Animal Health v. Council, supra note 10, pp. 170–172.

17

EMA, ‘COVID-19 vaccines: development, evaluation, approval and monitoring’, EMA (2021), available online at https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/vaccines-covid-19/covid-19-vaccines-development-evaluation-approval-monitoring (accessed 15 October 2021).

18

International Federation of Pharmaceutical Manufacturers and Associations, ‘The Complex Journey of a Vaccine – The Steps behind Developing a New Vaccine’, IFPMA (29 July 2019), available online at https://www.ifpma.org/resource-centre/the-complex-journey-of-a-vaccine-final/, accessed 15 October 2021.

19

Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use OJ L 311, 2001, pp. 67–128.

20

Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance) OJ L 136, 2004, pp. 1–33.

21

See Annex to Regulation (EC) No. 726/2004.

22

Article 6 Regulation (EC) No. 726/2004, supra note 21.

23

Commission Regulation (EC) No. 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No. 726/2004 of the European Parliament and of the Council (Text with EEA relevance) OJ L 92, 2006, pp. 6–9.

24

For more information on the Covid-Etf, see: https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/emas-governance-during-covid-19-pandemic#covid-19-ema-pandemic-task-force-section.

25

Regulation (EU) 2020/1043 of the European Parliament and of the Council of 15 July 2020 on the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease (COVID-19) OJ L 231, 2020, pp. 12–16.

26

CJEU 2 December 2004, European Commission v. The Netherlands, C-41/02, EU:C:2004:762, paras 51–52; CJEU 22 December 2010, Gowan Comércio Internacional and Servicos Lda, C-77/09, EU:C:2010:803, para. 73; CJEU 8 July 2010, Afton Chemical Limited, C-343/09, ECLI:EU:C:2010:419, para. 62.

27

D. Bourg and J.L. Schlegel, Parer aux risques de demain, Le principe de précaution (Paris: Seuil, 2000), p. 36.

28

U. Beck, La société du risque. Sur la voie d’une autre modernité, traduction (Paris: Champs Essais, 2001).

29

World Health Organisation, Coronavirus disease (COVID-19) science conversation, available online at https://www.who.int/emergencies/diseases/novel-coronavirus-2019/media-resources/science-in-5 (accessed 15 October 2021); World Health Organisation, Global research on coronavirus disease (COVID-19), available online at https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov (accessed 15 October 2021).

30

EU Commission, Coronavirus response, available online at https://ec.europa.eu/info/live-work-travel-eu/coronavirusresponse_fr (accessed 15 October 2021).

31

D. Utrilla and A. Shabbir, (eds.), EU law in times of pandemic, The EU’s legal response to Covid-19 (Granada: EU Law Live press, 2021); E. Dubout and F. Picod, Coronavirus et droit de l’Union européenne (Brussels: Bruylant, 2021).

32

N. De Sadeleer, ‘Securité alimentaire et précaution’, in: S. Mahieu and K. Merten Lentz (eds.), Sécurité alimentaire. Nouveaux enjeux et perspectives (Brussels: Bruylant, 2013) pp. 312–313.

33

EU Commission, Communication of the Commission on the precautionary principle, COM (2000)1 final, p. 7; European Environmental Agency, Late lessons from early warnings: science, precaution, innovation, Copenhagen, 2013, p.631; GC 11 September 2002, Pfizer Animal Health vs Council, T-13/99, supra note 11, para. 394; CJEU 8 July 2010, Afton Chemical Limited, C-343/09, EU:C:2010:419, supra note 29, para. 59.

34

G. Caggiano, E. Castelnuovo and R. Kima, ‘The global effects of Covid-19-induced uncertainty’, Economic Letters 194 (2020) DOI: 10.1016/j.econlet.2020.109392.

35

GC, 21 October 2003, Solvay Pharmaceuticals BV v Council of the European Union, ECLI:EU:T:2003:277, para. 124.

36

M. Nicod (ed.), Les affres de la qualification juridique (Toulouse: Institut Fédératif de Recherche ‘Mutation des normes juridiques’ – Université Toulouse I, 2016) p. 3.

37

Donati, supra note 13, p. 197.

38

NRC, Risk assessment in the Federal Government: Managing the Process (Washington, DC: National Academies Press, 1983) p. 13.

39

After the judgment GC 11 September 2002, Pfizer Animal Health vs Conseil, supra note 11, the case law of the Court of justice and the General Court is constant. For some recent examples, see: CJEU 24 October 2019, Prato Nevoso Termo Energy Srl v. Provincia di Cuneo et ARPA Piemonte, C-212/18, EU:C:2019:89 para. 58; CJEU 10 October 2019, Luonnonsuojeluyhdistys Tapiola, C-674/17, EU:C:2019:851, para. 66; CJEU 28 January 2010, Commission v. French Republic, C-333/08, EU:C:2010:44, para. 92; CJEU 28 March 2019, Verlezza e.a., C-487/17 à C-489/17, EU:C:2019:270, para. 57.

40

CJEU 28 January 2010, Commission v. French Republic, C-333/08, EU:C:2010:44, para. 92.

41

Conclusions of Advocate General M. Poiares Maduro in the case CJCE 2 December 2004, Commission v. The Netherlands, C-41/02, supra note 29, para. 34.

42

EU Commission, Communication of the Commission on the collection and use of expertise by the Commission: principles and guidelines, COM (2002) 713 final, pp. 8–10.

43

EU Commission, Communication of the Commission on the precautionary principle, COM (2000)1 final, p. 3.

44

R. Encinas de Munagorri, ‘Quel statut pour l’expert?’, Revue Française d’Administration Publique 3 (103) (2002) 379–389.

45

EMA, ‘EMA initiatives for acceleration of development support and evaluation procedures for COVID-19 treatments and vaccines’, EMA (16 September 2021), EMA/213341/2020 Rev.3.

46

EMA, ‘EMA plan for emerging health threats’, EMA (10 December 2018), EMA/863454/2018.

47

For more information, see: https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/transparency-exceptional-measures-covid-19-medicines (accessed 15 October 2021).

48

European Ombudsman, European Ombudsman’s inquiry into EMA’s pre-submission activities (OI/7/2017/KR), available online at https://www.ombudsman.europa.eu/en/decision/en/116683 (accessed 15 October 2021).

49

EMA, ‘Mandate, objectives and rules of procedure of the COVID-19 EMA pandemic Task Force (COVID-ETF)’, EMA (20 June 2021), EMA/166423/2020 Rev. 11, p. 5.

50

CJCE 9 September 2003, Monsanto Agricoltura Italia, C-236/01, EU:C:2003:431, paras 113–114.

51

CJEU 22 December 2010, Gowan Comércio Internacional and Servicos Lda, C-77/09, supra note 32., p. 73; GC 12 April 2013, Du Pont de Nemours (France) SAS and others v. European Commission, T-31/07, ECLI:EU:T:2013:167, p. 140.

52

Regulation (EU) 2020/1043, supra note 28, whereas 17.

53

Ibid.

54

Directive 2001/20EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, Article 2.

55

Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC – Commission Declaration, OJ L 106, 2001, pp. 1–39, Article 1 and Articles 6–11.

56

Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms, OJ L 125, 2009, pp. 75–97, Articles 4–13.

57

N. De Sadeleer, Environmental Principles from Political slogans to legal rules (Oxford: Oxford University Press, 2002) p. 184.

58

GC 16 September 2013, Animal Trading Company and others v. European Commission, T-333/10, EU:T:2013:451.

59

CJEU 11 July 2013, French Republique v. European Commission, C-601/11, EU:C:2013:465.

60

GC 21 October 2003, Solvay Pharmaceuticals v. Council, supra note 38.

61

GC 17 May 2018, Bayer CropScience AG v. European Commission, supra note 11. This has been recently confirmed by the Court of Justice in the appeal, CJEU 6 May 2021, Bayer CropScience AG and Bayer AG v European Commission, C-499/18 P, EU:C:2021:367.

62

CJEU 13 March 2019, Poland v. European Parliament and Council of the European Union, C-128/17, ECLI:EU:C:2019:194.

63

European Commission, Communication from the Commission on the precautionary principle, COM/2000/0001 final, p. 19.

64

EMA, Pharmacovigilance Plan of the EU Regulatory Network for COVID-19 Vaccines, EMA/333964/2020.

65

EMA, ‘Safety of COVID-19 vaccines’, EMA (2021), available online at https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/vaccines-covid-19/safety-covid-19-vaccines (accessed 15 October 2021).

66

On the comitology see: C.F. Bergström, Comitology: Delegation of Powers in the European Union and the Committee System (Oxford: Oxford University Press, 2005).

67

State of the Union Address by President von der Leyen, 15 September 2021, available online at https://ec.europa.eu/commission/presscorner/detail/en/SPEECH_21_4701.

68

Ibid.

69

See supra note 11.

70

See, mainly, the following documents: EU Commission, Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, Pharmaceutical Strategy for Europe, COM/2020/761 final; EU Commission, Proposal for a regulation of the European Parliament and of the Council on serious cross-border threats to health and repealing Decision No 1082/2013/EU, COM/2020/727 final, EU Commission, Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, Building a European Health Union: Reinforcing the EU’s resilience for cross-border health threats, COM/2020/724 final.

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