26 Amendments of Lina GÁLVEZ related to 2020/0321(COD)
Amendment 67 #
Proposal for a regulation
Recital 2
Recital 2
(2) The unprecedented experience of the COVID-19 pandemic has demonstrated that the Union should be more effective in managing the availability of medicinal products and medical devices and in developing medical countermeasures to address the threats posed to public health. The Union’s ability to do so has been severely impeded by the absence of a clearly defined legal framework for managing its response to the pandemic, and also by the limited degree of Union preparedness in case of a public health emergency impacting a majority of Member States. The pandemic has also shown the necessity of having an innovative and research based pharmaceutical industry that works closely with EMA in order to be better prepared for future health crisis and disruptions in the supply chain. COVID- 19 also underlined the need for more transparency on medicines pricing and EU marketing authorisation.
Amendment 74 #
Proposal for a regulation
Recital 4 a (new)
Recital 4 a (new)
(4 a) The COVID-19 pandemic is a clear example of the need to reinforce the application of the One Health approach in the EU to achieve better public health outcomes, since, as stated in the EU4Health Programme, human health is connected to animal health and the environment and actions to tackle threats to health should take into account those three dimensions.
Amendment 83 #
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9 a) The outbreak of COVID-19 and the subsequent health crisis revealed the need for a more coordinated European approach in crisis management. Although the emergency of the situation explains the lack of an impact assessment, sufficient allocation of resources in terms of staff and funding needs to be secured, taking into account the specificities of the health sector in the different Member States.
Amendment 84 #
Proposal for a regulation
Recital 10
Recital 10
(10) In order to ensure a better functioning of the internal market of those products and contribute to a high level of human health protection, it is therefore appropriate to approximate the rules on monitoring of shortages of medicinal products and medical devices, and to facilitate the research and development of medicinal products, which may have the potential to treat, prevent, or diagnose diseases that cause public health crises. Highlights in this respect the necessity of developing analytics to predict emerging risks, including the use of alternative data sources.
Amendment 99 #
Proposal for a regulation
Recital 20
Recital 20
(20) Individual research entities may agree together, or with another party, to act as a sponsor in order to prepare one harmonised Union-wide clinical trial protocol, yet experience during the COVID-19 pandemic has shown that initiatives to set up large multinational trials struggle to materialise due to the lack of a single entity that can undertake all the responsibilities and activities of a sponsor within the Union, while interacting with multiple Member States. It is therefore appropriate for the Agency to identify and facilitate such initiatives by giving advice on the possibilities to act as a sponsor or, where applicable, to define respective responsibilities as co-sponsors in accordance with Article 72 of Regulation (EU) 536/2014. Such an approach would strengthen the research environment in the Union, andwhile encouraging the collaboration with external experts including academia, and target recruitment of data scientists, omics specialists, biostatisticians, epidemiologists, and experts in advanced analytics and AI, as well as to promote harmonisation and avoid subsequent delays in integrating the results of research to a marketing authorisation. A Union sponsor could benefit from Union research funding available at the time of the public health emergency as well as existing clinical trial networks to facilitate the development, application, submission, and running of the trial. This may be particularly valuable for trials established by Union or international public health or research organisations.
Amendment 106 #
Proposal for a regulation
Recital 25
Recital 25
(25) In order to facilitate the work and the exchange of information under this Regulation, provision should be made through further implementing acts with a view to outlining the roles of the actors involved in the processing of personal data for the establishment and management of IT infrastructures and synergies with other existing IT systems or systems under development, including the EUDAMED IT platform for medical devices and Data Analysis and Real World Interrogation Network - DARWIN. That work should also be facilitated by, where appropriate, emerging digital technologies such as computational models and simulations for clinical trials, as well as data from the EU Space Programme such as the Galileo geolocation services, and Copernicus earth observation data, while enabling data discoverability.
Amendment 109 #
Proposal for a regulation
Recital 25 a (new)
Recital 25 a (new)
(25 a) Underlines the potential of Big Data to complement the evidence from clinical trials and fill knowledge gaps on medicines, as well as to help to better characterise diseases, treatments and the performance of medicines in individual healthcare systems. The global pandemic has also shown how High Performance Computing, in combination with Big Data and AI, can be of critical importance in the global fight against COVID-19.
Amendment 111 #
Proposal for a regulation
Recital 26
Recital 26
(26) Rapid access and exchange of health data, including real world data i.e. health data generated outside of clinical studies, such as electronic health records, insurance claims data and data from patient registries, is essential to ensure effective management of public health emergencies and other major events. This Regulation should allow the Agency to use and facilitate such exchange and be part of the establishment and operation of the European Health Data Space infrastructure, while ensuring the applicability of the GDPR and EUDPR, and the respect of the principles relating to the processing of personal data (as per Article 5 GDPR and 4 EUDPR).
Amendment 116 #
Proposal for a regulation
Recital 26 a (new)
Recital 26 a (new)
(26 a) The handling of sensitive health data requires a high level of protection against cyber-attacks. The Agency was the target of a cyber-attack that resulted in some of the unlawfully accessed documents related to COVID-19 medicines and vaccines belonging to third parties. Highlights in this respect the need for a high level of security against cyber- attacks, and particularly cyber-espionage, at all times and especially during public health emergencies;
Amendment 117 #
Proposal for a regulation
Recital 26 a (new)
Recital 26 a (new)
(26 a) Calls for the swift implementation of binding rules on security information and cybersecurity in line with the Security Union Strategy. Urges the Member States to accelerate the work towards completing the implementation of the main 5G Toolbox measures by the second quarter of 2021;
Amendment 145 #
Proposal for a regulation
Article 2 – paragraph 1 – point f
Article 2 – paragraph 1 – point f
(f) ‘major event’ means an event which is likely to pose a serious risk to public health in relation to medicinal products in more than one Member State. Such an event concerns a deadly threat or otherwise serious threat to health of biological, chemical, environmental or other origin or incident that can affect the manufacturing, supply or quality, safety, and efficacy of medicinal products. Such an event may lead to shortages of medicinal products in more than one Member State and necessitates urgent coordination at Union level in order to ensure a high level of human health protection.
Amendment 167 #
Proposal for a regulation
Article 4 – paragraph 5 – point a
Article 4 – paragraph 5 – point a
(a) where the major event or public health emergency may affect the manufacturing, safety, quality, and efficacy of medicinal products, Article 5 shall apply;
Amendment 169 #
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
Following the recognition of a public health emergency or a request for assistance referred to in Article 4(3), the Medicines Steering Group shall evaluate the information related to the major event or the public health emergency and consider the need for urgent and coordinated action with regard to the manufacturing safety, quality, and efficacy of the medicinal products concerned.
Amendment 195 #
Proposal for a regulation
Article 9 – paragraph 1 – point a
Article 9 – paragraph 1 – point a
(a) specify the procedures and criteria for establishing the critical medicines lists;
Amendment 202 #
Proposal for a regulation
Article 9 – paragraph 1 – point c
Article 9 – paragraph 1 – point c
(c) develop streamlined electronic monitoring and reporting systems in coordination with the national competent authorities;
Amendment 247 #
Proposal for a regulation
Article 14 – paragraph 2 – point f
Article 14 – paragraph 2 – point f
(f) cooperating with national competent authorities, Union bodies and agencies, the World Health Organization, third countries, and international scientific organisations on scientific and technical issues relating to the public health emergency and to medicinal products which may have the potential to address public health emergencies, as necessary.
Amendment 262 #
Proposal for a regulation
Article 15 – paragraph 6
Article 15 – paragraph 6
6. Where a developer is the recipient of scientific advice, the developer shall subsequently submit the data resulting from clinical trials to the Agency following a request made pursuant to Article 16. In order to ensure the protection of sensitive data a state-of-the-art pseudonymisation shall apply, including encryption.
Amendment 268 #
Proposal for a regulation
Article 16 – paragraph 2
Article 16 – paragraph 2
2. In preparation of the review, the Emergency Task Force may request information and data from marketing authorisation holders and from developers and engage with them in preliminary discussions. The Emergency Task Force may also, where available, make use of observational studies of health data generated outside of clinical studies taking into account their reliability, while applying state-of-the-art pseudonymisation, including encryption.
Amendment 275 #
Proposal for a regulation
Article 18 – paragraph 1 – point a
Article 18 – paragraph 1 – point a
(a) develop and maintain electronic tools for the submission of information and data, including electronic health data generated outside the scope of clinical studies, while ensuring processing of patients' personal data is in compliance with the European data protection framework;
Amendment 277 #
Proposal for a regulation
Article 18 – paragraph 1 – point b
Article 18 – paragraph 1 – point b
(b) coordinate independent vaccine effectiveness and safety monitoring studies using relevant data held by public authorities, while taking into consideration the priority recommendations of the HMA-EMA joint Big Data Task Force. Such coordination shall be conducted jointly with the European Centre for Disease Prevention and Control and notably through a new vaccine monitoring platform;
Amendment 278 #
Proposal for a regulation
Article 18 – paragraph 1 – point c
Article 18 – paragraph 1 – point c
(c) as part of its regulatory tasks, make use of digital infrastructures or tools, to facilitate the rapid access to or analysis of available electronic health data generated outside the scope of clinical studies, and the exchange of such data between Member States, the Agency, and other Union bodies; underlines in this regard the need to speed up the deployment of a secure quantum communication infrastructure (QCI), which would allow the transmission of sensitive information, using an ultra-secure form of encryption to shield against cyberattacks;
Amendment 279 #
Proposal for a regulation
Article 18 – paragraph 1 – point c a (new)
Article 18 – paragraph 1 – point c a (new)
(c a) The Agency shall be equipped with a high level of security against cyber- attacks and cyber-espionage at all times, especially during major events and public health emergencies at Union level. Binding rules on security information and cybersecurity shall apply in line with the Security Union Strategy.
Amendment 300 #
Proposal for a regulation
Article 23 – paragraph 1 – point a
Article 23 – paragraph 1 – point a
(a) specify the procedures and criteria for establishing the public health emergency critical devices list;
Amendment 301 #
Proposal for a regulation
Article 23 – paragraph 1 – point b
Article 23 – paragraph 1 – point b
(b) develop streamlined electronic monitoring and reporting systems in coordination with the national competent authorities;
Amendment 319 #
Proposal for a regulation
Article 30 – paragraph 1 – point a
Article 30 – paragraph 1 – point a
(a) personal data in accordance with Article 32 and Article 4(1) of Regulation (EU) 2016/679 (‘GDPR’) and Article 3(1) EUDPR;
Amendment 321 #
Proposal for a regulation
Article 30 – paragraph 5
Article 30 – paragraph 5
5. The Commission, the Agency, and Member States may exchange commercially confidential information and, where necessary to protect public health, personal data, with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements. Recalls that transfers of personal data to third countries or international organisations must comply with Chapter V of the EUDPR, relevant provisions of the GDPR, the LED and the Charter of Fundamental Rights and take into account the recommendations and guidelines of the EDPB.