Activities of Luisa REGIMENTI related to 2021/2013(INI)
Plenary speeches (1)
A pharmaceutical strategy for Europe (debate)
Opinions (1)
OPINION on a pharmaceutical strategy for Europe
Amendments (11)
Amendment 2 #
Draft opinion
Paragraph 1
Paragraph 1
1. Stresses the importance of developing a new EU pharmaceutical strategy which is consistent with the Union’s competences under the Treaties and with the principles of proportionality and subsidiarity, as a means of stimulating the development of European enterprises and making them competitive at global level, of paving the way for scientific progress and of guaranteeing better prevention and preparedness and more effective responses to future health emergencies; stresses the need to draw up future European framework provisions for regulatory approval, access and incentives for innovation, accompanied by vigorous industrial policies, with attractiveness and predictable rules being regarded as the key to innovation, and to facilitate patients’ access to medicines; notes that EU pharmaceutical strategy and legislative measures must support European developers and producers in guiding scientific progress and remaining globally competitive; draws attention to the need to develop production chains within Europe through the formulation of rational regulatory framework provisions that are compatible between the Member States, thereby ensuring the supply of medicines by safeguarding the entire production process;
Amendment 25 #
Draft opinion
Paragraph 2
Paragraph 2
2. Emphasises the key importance of intellectual property protection in the EU, which is essential if the EU is not to be dependent on third countries and is to enhance its strategic autonomy in the field of medicines; calls for a joint review process involving European, national and regional institutions, along with health professionals, industry representatives and stakeholders, with a view to identifying shared approaches, in particular to the challenges posed by the COVID-19 pandemic; stresses that compulsory licensing should only be possible in exceptional cases, where no other solution can be found and where it appears to be justified and necessary to increase production capacity effectively;
Amendment 31 #
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Stresses that intellectual property plays a pivotal role in the expansion and growth of SMEs, which are penalised by a lack of knowledge of procedures and by inadequate or non-existent information regarding opportunities available to them;
Amendment 32 #
Draft opinion
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Stresses the need for the Commission, the Member States and the holders of marketing authorisations for medicines to work together in order to identify and address the root causes of the shortfall in medicines on EU markets and to find appropriate ways of addressing the remaining barriers to timely and effective patient access; stresses that affordability of medicines remains a challenge for national health systems;
Amendment 33 #
Draft opinion
Paragraph 2 c (new)
Paragraph 2 c (new)
2c. Stresses the importance of building adequate legal and operational frameworks that give industry the necessary agility and flexibility to quickly rebuild stockpiles based on patients’ needs in each country and using regional supply strategies; underscores the need for regulatory solutions that encourage flexible and adaptable production and distribution strategies; highlights the need for dialogue with industry to find viable solutions that increase common capacity to prevent shortages;
Amendment 45 #
3. Stresses the importance of investment and supporting for research in the EU, not least in order to increase the number of patents filed in the Member States; stresses that one of the priorities should be to develop medicines in areas where needs have been met only insufficiently or not at all or where commercial interest is low, to be decided in close collaboration with interested parties, that is to say patients, consumers, healthcare professionals and not-for- profit researchers, and based on the added value to the patient, taking into account the severity of the disease, the costs and the alternative treatments possible; notes that public research should focus particularly on areas of low commercial interest; draws attention, in that connection, to the key role played by AI and its potential as a driver of research and development in the health and pharmaceutical sector;
Amendment 50 #
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Stresses that full realisation of the potential of new technologies also depends on the proper use of health data; stresses the importance of using the potential of digital technologies and health data to expedite access to innovative technologies and to help Member States develop the infrastructure necessary to better assess safety data, health benefits and outcomes; notes that the current COVID-19 crisis has already highlighted the usefulness of data sharing in expediting research, and stepping up public health surveillance systems across the EU with the intention of saving lives;
Amendment 51 #
Draft opinion
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Calls on the Commission to draw up guidelines to resolve problems relating to the interpretation of GDPR provisions on sharing health data for scientific purposes and a code of conduct for the processing of personal data in the health sector in accordance with Article 40 of the GDPR; recommends that appropriate consultations be carried out with the Member States and the scientific community in the implementation of these actions, so that the future health data space can truly fulfil its ambition to support scientific and medical research in Europe;
Amendment 73 #
Draft opinion
Paragraph 5
Paragraph 5
5. Calls on the Commission to use all the means at its disposal to prevent counterfeit products from entering the market and so protect intellectual property rights holders and European citizens, as these products are often of low quality and pose a danger to health; notes that this is compounded by the heavy economic impact, estimated at a loss of at least EUR 10 billion for the European pharmaceutical industry and 37 000 jobs; notes that it is necessary to provide technical assistance to the Member States for the proper implementation of the EMVS;
Amendment 77 #
Draft opinion
Paragraph 5 b (new)
Paragraph 5 b (new)
5b. Stresses the need to relocate the production of the most essential medicines into the EU; calls, therefore, on the Commission to prioritise the pharmaceutical production of vaccines in the EU, enabling Member States to conclude public contracts with the various European pharmaceutical laboratories producing vaccines in order to avoid a shortage of doses and ensure the safety of European citizens in the face of such a crisis;
Amendment 569 #
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Emphasises that the term medical device means any instrument, device, item of equipment, software package, implant, reagent, material or other article intended by the manufacturer for use on human beings. If the medical device is to be used alone or in combination with other substances, the Commission is asked to refer to rule 21 in Annex VIII to Regulation 745/2017 on the classification of medical devices;