Activities of Jutta PAULUS related to 2020/2071(INI)
Shadow opinions (1)
OPINION on shortage of medicines - how to address an emerging problem
Amendments (14)
Amendment 1 #
Draft opinion
Recital -A (new)
Recital -A (new)
-A. whereas the problem of medicines shortages in the EU is long-standing and the number of incidents relating to medicines shortages has been growing in the EU Member States in recent years;
Amendment 2 #
Draft opinion
Recital -A a (new)
Recital -A a (new)
-A a. whereas the dependency on suppliers from a small number of third countries – the overwhelming majority of chemical raw and starting materials and active pharmaceutical ingredients (API) used for manufacturing of medicinal products for the EU market come from India and China – leads to the vulnerability of the EU health systems; whereas causes of most incidents relating to medicines shortages can be traced to disruption in the early stages of supply chains;
Amendment 3 #
Draft opinion
Recital -A b (new)
Recital -A b (new)
-A b. whereas production of chemical raw and starting materials and active pharmaceutical ingredients in the EU has been affected by the tendering system based on the criterion of lowest price, which incentivises the outsourcing of such production to third countries and therefore harming European companies with higher standards; whereas some facilities in these third countries often lack the capacity to enforce adherence to adequate standards of sustainable and ethical production of these materials and ingredients; whereas single winner tender systems are endangering the diversification of sources and leading to possible shortages;
Amendment 7 #
Draft opinion
Recital A
Recital A
A. whereas the coronavirus pandemic has exacerbillustrated the growing problem of medicine shortages across the EU; whereas the ensuing disruption of the globalvulnerabilities of many supply chains has highlightedwell as the EU’s dependency on third countries for medicines and active pharmaceutical ingredients; whereas the EU’s reliance on imports in this area and the lack of diversification created additional threats to the EU’s capacity to provide a prompt and adequate response to the health emergencies;
Amendment 15 #
Draft opinion
Recital A a (new)
Recital A a (new)
A a. whereas parallel trade and export bans could affect the availability of medicines in some Member States; whereas the Commission launched a study on the impact of the parallel trade;
Amendment 55 #
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1 a. Calls for an overhaul of the EU- wide early warning system that would provide a comprehensive picture and issue regular and timely alerts on potential shortages of medicines; insists that within this system, all stakeholders in the supply chain, including parallel traders and wholesalers, should have an obligation to report in a timely manner on potential disruptions; states that the deadline of two months for the current reporting obligation doesn´t leave enough time to act, calls for better enforcement of legal reporting obligations; calls for a more central role for the European Medicine Agency in an EU-wide early warning system that includes, in addition to the aforementioned stakeholders, hospital pharmacists and patient associations;
Amendment 65 #
Draft opinion
Paragraph 2
Paragraph 2
2. Calls on the Commission to consider proposing requirements forchanges in the marketing authorisation framework that require the pharmaceutical industry to ensure that its supply chain is diversified, identifying alternatives for each component of the supply chain akin to the principle of N-1 redundancy in electrical grid operation and put in place a mandatory medicine shortage risk mitigation plan to manage any vulnerabilities in and risks to the supply chain and submit these plans to competent authorities; calls on the Commission to seek harmonisation and enforcement of such requirements across the Union;
Amendment 86 #
Draft opinion
Paragraph 3
Paragraph 3
3. Stresses the urgent need for the EU to reduce its over-reliance on a small number of third countrnon-EU manufacturers and suppliers for medicof chemical raw and startineg manufacturing and as sources of active pharmaceutical ingredientsterials and active pharmaceutical ingredients (API) and calls for additional safeguards to ensure that materials and ingredients entering the EU market are produced in accordance with adequate social and environmental standards; proposes to include the aforementioned standards into the GMP framework;
Amendment 101 #
Draft opinion
Paragraph 4
Paragraph 4
4. EncouraUrges the Commission to propose measures in its planned pharmaceutical strategy, including financial incentives, to promote green manufacturing, within the EU, of strategically important chemicals used in medicine production; calls on Member States to review tendering systems in order to reward sustainable, ethical and quality manufacturing; encourages the creation of the active pharmaceutical ingredients alliance to strengthen the global competitiveness of EU manufacturers and facilitate the rebalancing of the value chain towards the EU; urges the Commission to also propose measures to incentivise the greater inclusion of EU small and medium-sized enterprises in the medicine supply chain given their key role in research and innovation and inherent ability to quickly adapt their production focus, with a view to coping better with unexpected shocks;
Amendment 112 #
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4 a. Highlights the importance of assessing the impact of parallel trade and export bans from the perspective of patient access; calls on the Commission to develop additional guidance as necessary for Member States on parallel exports; stresses the need to include the perspective and experiences of patient and consumer groups;
Amendment 122 #
Draft opinion
Paragraph 5
Paragraph 5
5. Highlights the fact that Horizon 2020 has already financed a significant number of health-related research and innovation activities; underlines that the funding of coronavirus-related research should not affect other health priorities of Horizon 2020; calls for making funding conditional on ensuring wide availability and affordability of R&D products vital in health emergencies, including the possibility to require non- exclusive licensing; calls for more funding to be provided through Horizon Europe to create and support medicine- focused research ecosystems. ;
Amendment 133 #
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. Welcomes the initiative of Commissioner Reynders to propose a due diligence law for companies in 2021; calls on the Commission to incorporate measures for the pharmaceutical sector into this proposal;
Amendment 140 #
Draft opinion
Paragraph 5 b (new)
Paragraph 5 b (new)
5 b. States that the current COVID-19 crisis shows the need for more European cooperation in the health sector, calls for more EU competences in the sector; demands an increased rescEU budget to facilitate future common European procurement of medicine, vaccines, medical devices and protective gear;
Amendment 143 #
Draft opinion
Paragraph 5 c (new)
Paragraph 5 c (new)
5 c. Highlights the dangers of neglecting environmental standards in production, as e.g. possible unlawful disposal of waste water containing toxic substances does not only harm the environment but can also lead to serious health threats; recalls the serious danger of growing antimicrobial resistance (AMR) through uncontrolled release of antibiotics in the environment both through factory farming and through API production without proper waste (water) treatment; reminds of the “EU One Health Action Plan against Antimicrobial Resistance”; stresses that Europe has a global responsibility in containing AMR and that non-compliance to environmental standards should be a knock-out criterion for API and chemicals providers;