Explanatory Memorandum to COM(2020)261 - Conduct of clinical trials with and supply of medicinal products for human use containing or consisting of GMOs intended to treat or prevent coronavirus disease - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2020)261 - Conduct of clinical trials with and supply of medicinal products for human use containing or consisting of GMOs intended to ... |
|---|---|
| source | COM(2020)261  |
| date | 17-06-2020 |
1. CONTEXT OF THE PROPOSAL
Contents
The environmental risks of all medicinal products are assessed as part of the marketing authorisation procedures, including for medicinal products that contain or consist of genetically modified organisms (“GMOs”).
The Union legislation on GMOs encompasses Directive 2009/41/EC on the contained use of genetically modified microorganisms (the “contained use Directive”) and Directive 2001/18/EC on the deliberate release into the environment of GMOs (the “deliberate release Directive”). Directive 2001/20/EC on clinical trials is without prejudice to the application of the GMO Directives. There is not a common approach for assessment of GMO aspects of clinical trials with investigational medicinal products for human use in the EU as some Member States apply the deliberate release Directive, other Member States apply the contained use Directive and others decide on a case-by-case basis or apply both.
The purpose of the Union legislation on GMOs is to protect both human health and the environment. However, the specific characteristics of the setting of clinical trials in a situation of a public health emergency such as the one created by the COVID-19 pandemic are not foreseen in Directive 2001/18/EC or Directive 2009/41/EC.
The Coronavirus outbreak has created an unprecedented public health emergency. The development of vaccines and therapies against the virus is of major public interest and we are collectively called to make safe and efficacious medicinal products available to our citizens as soon as possible. Some of the vaccines under development are based on genetically modified viruses and may fall within the definition of GMO. It is necessary to adapt the regulatory framework on GMOs so that the conduct of clinical trials with these vaccines can start within the shortest possible timelines while ensuring the rights, safety, dignity and well-being of those individuals that take part in a clinical trial, as well as the reliability and robustness of the data generated and adequate protection of the environment and of human health via the environment.
Doubts have been raised by some Member States regarding the application of the provisions of Directive 2001/18/EC and Directive 2009/41/EC in the situations contemplated in Article 5(1) and (2) of Directive 2001/83/EC and Article 83 of Regulation (EC) No 726/2004. These provisions allow Member States to authorise the supply and administration of medicinal products for human use (including medicinal products that contain or consist of GMOs) in the absence of a marketing authorisation where there is an urgent need to address the specific needs of a patient, for compassionate use, or in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation that could cause harm.
In those exceptional and urgent situations, where there is a lack of a suitable approved medicinal product, the Union legislator has made a choice that the need to protect public health or the health of individual patients and the benefits of the medicinal product must prevail over other considerations, in particular the need to obtain a marketing authorization and consequently, to have available complete information about the risks posed by the medicinal product, therefore including any risks to the environment from medicinal products containing or consisting of GMOs.
It would be incoherent and contrary to the very purpose and “effet utile” of those exemptions, and with the objective of protecting human health in Directive 2001/18/EC, Directive 2009/41/EC and in Union legislation on medicinal products, to consider that it was the legislator’s intention to still require an authorization under Directive 2001/18/EC or Directive 2009/41/EC when the legislator, taking into account the objective of protecting human health and the environment has made a choice that in those exceptional and urgent situations the protection of public health or the health of individual patients must prevail and has provided an exemption from the authorization procedure in the Union legislation on medicinal products. Therefore, where Member States adopt decisions pursuant to Article 5(1) and (2) of Directive 2001/83/EC or Article 83(1) of Regulation (EC) No 726/2004 concerning medicinal products containing or consisting of GMOs, an environmental risk assessment and/or consent in accordance with Directive 2001/18/EC or Directive 2009/41/EC are not a prerequisite.
In the current situation of public health emergency created by the COVID-19 pandemic, it is necessary to clarify the interpretation of Article 5(1) and (2) of Directive 2001/83/EC and Article 83(1) of Regulation (EC) No 726/2004 to avoid divergent interpretations and to ensure equal and as prompt as possible access to medicinal products for human use intended to treat or prevent COVID-19. Therefore, it should be clarified that, where Member States adopt decisions pursuant to Article 5(1) and (2) of Directive 2001/83/EC or Article 83(1) of Regulation (EC) No 726/2004 concerning medicinal products containing or consisting of GMOs intended to treat or prevent COVID-19, an environmental risk assessment and/or consent in accordance with Directive 2001/18/EC or Directive 2009/41/EC are not a prerequisite.
The policy objective of this proposed Regulation is to ensure that clinical trials with medicinal products for human use that contain or consist of GMOs and are intended to treat or prevent COVID-19 can start swiftly and without a prior environmental risk assessment and/or consent under Directive 2001/18/EC or Directive 2009/41/EC in so far as there is a valid declaration of pandemic by the World Health Organisation, or if COVID-19 is declared an emergency situation in accordance with Decision No 1082/2013/EU and remains so.
In the situation of public health emergency created by the COVID-19 pandemic, there is an overriding interest in protecting human health. Moreover, the intrinsic characteristics of the conduct of clinical trials (i.e. limited number of patients, limited volumes of medicinal products involved and administration in a highly controlled environment), substantially limit any potential environmental exposure. Hospitals routinely deal with hazardous biological substances and protocols exist to ensure safe handling of biological waste in a hospital setting. In this context, the Commission has also adopted guidelines on waste management in the COVID-19 crisis 1 .
It is stressed that an environmental risk assessment for the medicinal products covered by this Regulation will be performed before they become widely available in the Union as part of the marketing authorisation procedure.
In addition, it should be clarified that medicinal products for human use containing or consisting of GMOs intended to treat or prevent COVID-19 can be administered swiftly in the absence of a prior environmental risk assessment and/or consent under Directive 2001/18/EC or Directive 2009/41/EC in the exceptional situations foreseen in Article 5(1) and (2) of Directive 2001/83/EC, and Article 83 of Regulation (EC) No 726/2004.
2.LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY
This proposal is based on Articles 114 and 168(4)(c) of the Treaty on the Functioning of the European Union (TFEU).
The proposed Regulation aims to expedite the conduct of clinical trials with medicinal products that contain or consist of GMOs in the current scenario of public health emergency created by the COVID-19 pandemic so as to facilitate the availability of high quality, safe and efficacious medicinal products to treat or prevent COVID-19. In so far as the proposed Regulation will allow Member States to facilitate the development and/or availability of high quality and safe medicinal products for human use in response to the situation of public health emergency created by the COVID-19 pandemic, the adoption thereof should be based on Article 168(4)(c) TFEU.
A common approach for all the Union Member States is deemed necessary as threats to health arising from the COVID-19 pandemic have, by their nature, transnational implications. Measures adopted by the Member States should be consistent with each other. Thus, the proposed Regulation aims to create a common approach for the conduct of clinical trials with medicinal products that contain or consist of GMOs intended to treat or prevent COVID-19 and to clarify aspects of the application of decisions by Member States taken in accordance with Article 5(1) and (2) of Directive 2001/83/EC and/or Article 83 of Regulation (EC) No 726/2004 to these products. Hence, the proposed Regulation should also be based on Article 114 of the TFEU.
The proposal builds on the experience gained with the existing regulatory framework for medicines as well as the experience in the application of the legislation on GMOs to medicinal products for human use. On the basis of the available evidence, it is concluded that it is unlikely that the concerns arising from the lack of tools in the Union legislation to address the specific characteristics of clinical trials with investigational medicinal products for human use that contain or consist of GMOs in the current situation of public health emergency created by COVID-19 will be resolved unless this situation is addressed at Union level.
In addition, the proposal also aims at clarifying certain aspects of the application of provisions of the pharmaceutical acquis that allow the national competent authorities to authorise the supply and administration of medicinal products that do not have a marketing authorisation to situations of urgency and/or emergency, such as the COVID-19 pandemic. Directive 2001/83/EC and Regulation (EC) No 726/2004 have created a harmonised framework and the clarifications proposed will contribute to optimise the implementation of Articles 5(1) and 5(2) of Directive 2001/83/EC and Article 83 of Regulation (EC) No 726/2004 for medicinal products for human use containing or consisting of GMOs intended to treat or prevent COVID-19.
The proposed rules aim at harmonising an area in which application of existing Union legislation and national measures have proven insufficient. Moreover, the proposal is limited in scope so as to avoid going beyond what is necessary to achieve the objectives pursued in the exceptional circumstances created by the COVID-19 pandemic.
3. RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS
The proposed Regulation has not been subject to a public consultation or a Commission Impact Assessment.
The proposal is targeted in scope and does not impose new obligations on the concerned parties.
4. BUDGETARY IMPLICATIONS
The proposal does not have a budgetary impact for the EU institutions.