15 Amendments of Jorge BUXADÉ VILLALBA related to 2021/2013(INI)
Amendment 7 #
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Notes the new European pharmaceutical strategy that is being presented as a fresh opportunity to enhance EU competitiveness and consolidate the role of European industry, thereby avoiding the relocation of companies outside the EU; stresses that this is also an opportunity for Member States to play a more prominent role at global level;
Amendment 15 #
Draft opinion
Paragraph 1 b (new)
Paragraph 1 b (new)
1b. Recalls that health falls within the remit of the Member States alone and that Union initiatives must remain within the framework laid down in Article 152 of the Treaty; points out in this regard that the EU must confine itself to complementing and facilitating measures by the Member States to achieve their objectives;
Amendment 30 #
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, nstresses that intellectual property rights enhance the accessibility, innovation and competitiveness of the sector and improve the safety of medicines and of patients; calls for the role of the Member States to be enhanced by improving communicational 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 pandemiccooperation between the European institutions, national authorities, health professionals, industry representatives and stakeholders;
Amendment 47 #
Draft opinion
Paragraph 3
Paragraph 3
3. Stresses the importance of supporting 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, such as orphan drugs, paediatric cancer therapies and antimicrobial resistance (AMR) drugs; calls for unmet needs and the concept of additional therapeutic value to be more closely defined; 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 58 #
Draft opinion
Paragraph 4
Paragraph 4
Amendment 74 #
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Stresses that, in order to keep the Member States globally competitive, any EU action must be free of ideological prejudices and focused on the development of a long-term strategy based on technically sound and simplified processes and the easing of burdens, in order to encourage the entry of a raft of new products on the market; stresses that changes to EU legislation are necessary in order to avoid moves towards industrial relocation outside EU borders;
Amendment 78 #
Draft opinion
Paragraph 5 b (new)
Paragraph 5 b (new)
5b. Calls on the Commission to develop, at minimum cost, a digital platform to serve as a contact point between Member States, providing channels of information, communication and advice in order to involve Member States in innovation projects at national and European level; encourages Member States accordingly to pool information regarding their practices in order to foster innovation;
Amendment 82 #
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Calls on the Commission, to facilitate public access to information regarding patenting and licensing conditions, the findings of clinical and pre-clinical trials and public and private contributions;
Amendment 84 #
Draft opinion
Paragraph 6 b (new)
Paragraph 6 b (new)
6b. Recalls that, in situations of crisis or health emergencies, changes to intellectual property rules are totally insufficient to meet short-term needs; calls on the Commission to endeavour to provide Member States with mechanisms and tools to ensure that, in exceptional situations and going beyond licensing policy, knowledge transfer is as effective as possible; calls on the Commission to consider the introduction of provisional regulatory mechanisms enabling Member States in exceptional circumstances to order and control the production of vaccines through the compulsory licensing of outside companies where they deem necessary;
Amendment 87 #
Draft opinion
Paragraph 6 c (new)
Paragraph 6 c (new)
6c. Stresses the need for greater transparency in the price of medicines, especially in order to make consumers aware of indirect taxes on medicines and healthcare products; recalls that prices are set at national level;
Amendment 88 #
Draft opinion
Paragraph 6 d (new)
Paragraph 6 d (new)
6d. Reminds the Commission that Member States are empowered to set their own priorities regarding innovative processes for the manufacture of new antibiotics; notes the need to facilitate access to new antibiotics while maintaining access to old ones;
Amendment 90 #
Draft opinion
Paragraph 6 e (new)
Paragraph 6 e (new)
6e. Calls for maximum transparency in the use of public research and development funding and for easy public access to information regarding patenting and licensing conditions, the findings of clinical trials and public/private contributions.
Amendment 91 #
Draft opinion
Paragraph 6 f (new)
Paragraph 6 f (new)
6f. Stresses the need to devote more resources at European level to combat unfair and abusive market practices with regard to medicines; underlines, in this regard, the need for new funding lines to support the work of new start-ups and SMEs in the field of medical biotechnology;
Amendment 92 #
Draft opinion
Paragraph 6 g (new)
Paragraph 6 g (new)
6g. Stresses that EU legislation frequently acts as a bottleneck, stifling many of the innovations that SMEs are seeking to market; calls on the EU to review its pharmaceutical policies with a view to becoming a global hub of medical innovation; points out that the EU should focus on developing adequate capacity for the production of active substances, raw materials and medicines, thereby reducing its dependence on external sources;
Amendment 93 #
Draft opinion
Paragraph 6 h (new)
Paragraph 6 h (new)
6h. Notes that innovation is far outstripping legislation; calls on the Commission to introduce a degree of regulatory flexibility in order to be able to respond more rapidly and effectively to new market requirements and demand for products;