Activities of Ivo HRISTOV related to 2021/2013(INI)
Shadow opinions (1)
OPINION on a pharmaceutical strategy for Europe
Amendments (21)
Amendment 2 #
Draft opinion
Recital A
Recital A
A. whereas the pandemic has revealed the limitations of the current set-up for managing value chains and accessibility to medicines and vaccineal products, including vaccines; whereas ensuring the strategic autonomy in the field of medicines and diversifying pharmaceutical manufacturing and supply chains represents an essential step in effectively tackling future pandemics;
Amendment 11 #
Draft opinion
Recital A a (new)
Recital A a (new)
A a. whereas ensuring interoperability of HPC with AI is of the utmost importance, as major economic sectors relying on HPC include manufacturing, health and pharmaceuticals.
Amendment 15 #
Draft opinion
Recital A a (new)
Recital A a (new)
A a. whereas the right to health is one of the core principles of the European Pillar of Social Rights;
Amendment 27 #
Draft opinion
Recital B
Recital B
B. whereas universalequitable access to safe, effective and affordable medicines is a fundamental right the full realisation of which is incompatible with a pharmaceutical model based primarily on the pursuit of profit;
Amendment 35 #
Draft opinion
Recital B a (new)
Recital B a (new)
B a. whereas global events such as the COVID-19 pandemic have shown the importance of investing in digital health technologies such as artificial intelligence and computer modelling and simulation, which accelerate the identification of critical components for the pharmaceutical sector as well as the testing of safety, efficacy and performance of new treatments;
Amendment 79 #
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1 a. Highlights the need to prioritise R&D for innovative medicines and treatments that better address patients needs, as well as to create incentives for up-skilling, re-skilling and out-skilling of workers for health care careers in order to be better prepared for potential emergency and crisis situations;
Amendment 109 #
Draft opinion
Paragraph 2
Paragraph 2
2. Calls on the Commission to keep the results of Union-funded R&D in the public domain; points out that the protection of patents must not run counter to the right to health; underlines that public interest and patient safety should be at the centre of all health policies, alongside investment and research;
Amendment 122 #
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2 a. Stresses that investment in research should deliver effective therapeutic treatments for patients with rare diseases, chronic diseases including cancer and paediatric cancers in particular;
Amendment 126 #
Draft opinion
Paragraph 2 b (new)
Paragraph 2 b (new)
2 b. Highlights the potential of AI- based solutions in reinforcing the resilience and sustainability of EU’s healthcare systems, while offering innovative therapies and better diagnosis using Real-World Data;
Amendment 127 #
Draft opinion
Paragraph 2 c (new)
Paragraph 2 c (new)
2 c. 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;
Amendment 129 #
Draft opinion
Paragraph 2 d (new)
Paragraph 2 d (new)
2 d. Stresses the need to develop European federated data networks aiming to contribute to optimal research, development and healthcare delivery;
Amendment 130 #
Draft opinion
Paragraph 2 e (new)
Paragraph 2 e (new)
2 e. Underlines the importance of data sharing and data accessibility in deploying the full potential of AI in the field of healthcare, while putting in place robust ethical requirements;
Amendment 131 #
Draft opinion
Paragraph 2 f (new)
Paragraph 2 f (new)
2 f. Recalls that the processing of data for health research purposes should comply with the provisions of GDPR under Article 9 on the processing of special categories of data;
Amendment 134 #
Draft opinion
Paragraph 3
Paragraph 3
3. Calls on the Commission to develop a new incentive model, look into decoupling mechanisms as an alternative to exclusive protections, and attach strict conditions to public funds in accordance with the principle of fair return on investment and prioritisation of public interest;
Amendment 142 #
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3 a. Highlights the latest evolution of pharmaceutical products towards disease and patient-specific therapeutics, involving scrupulous manufacturing steps and the need to take into account the high sensitivity to environmental and transport conditions and complicating supply chain logistics; invites the Commission to maximise synergies between European funds and other EU instruments and policies, to support the design and operation of robust manufacturing processes and distribution networks ensuring agile, responsive and reproducible manufacturing;
Amendment 162 #
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4 a. Considers that the interconnection and interoperability of High Performance Computing infrastructures with the European Health Data Space would ensure the availability of large, high- quality health data sets which are critically important for research and treatment of pathologies, especially rare diseases and paediatric conditions;
Amendment 174 #
Draft opinion
Paragraph 5
Paragraph 5
5. Calls for public investment in R&D to be made transparent and for it to be reflected in product availability and pricing; Calls in this regard on the Commission to increase price transparency when it comes to the costs calculated in the prices, while also addressing the causes limiting affordability;
Amendment 178 #
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. Underlines that it is estimated that around 30 million citizens in Europe suffer from a rare condition; is of the opinion that the barriers hampering a robust and effective research on rare diseases should be overcome, including those linked to the lack of large amount of data; calls for additional public support to carry out research in this field;
Amendment 201 #
Draft opinion
Paragraph 7
Paragraph 7
7. Calls on the Commission to promote joint procurement favourable to all member states and apply most economically advantageous tender (MEAT) criteria more stringently, while taking into account the need for more balance between public and private interests, including clear liability for manufacturers, as well as the need for sufficient flexibility for member states in line with national specificities; underlines the importance to improve security of supply and to enhance EU countries' preparedness to mitigate cross-border threats to health;
Amendment 210 #
Draft opinion
Paragraph 7 a (new)
Paragraph 7 a (new)
7 a. Welcomes the Commission proposal on the European institutionalised partnerships that will enable research in the health sector; welcomes the collaboration between the private and the public sector in this domain; recalls that research and innovation on pharmaceutical products should aim to enhance their accessibility, availability and affordability;
Amendment 215 #
Draft opinion
Paragraph 7 b (new)
Paragraph 7 b (new)
7 b. Calls for the strong involvement of patient and end-user associations as well as of representatives of health professionals in the design and the implementation of the Union’s initiatives enabling the Pharmaceutical Strategy for Europe;