Activities of Elżbieta KRUK related to 2020/2071(INI)
Shadow opinions (1)
OPINION on shortage of medicines - how to address an emerging problem
Amendments (5)
Amendment 4 #
Draft opinion
Recital A
Recital A
A. whereas the coronavirus pandemic has exacerbated the growing problem of medicine shortages across the EU; whereas the ensuing disruption of the global supply chain has highlighted the EU’s dependency on third countries for medicines and active pharmaceutical ingredients; whereas the limited access to Active Pharmaceutical Ingredients (APIs) required for the production of generic medicines poses a particular challenge with around 70% of APIs used in Europe being imported from third countries;
Amendment 19 #
Draft opinion
Recital A a (new)
Recital A a (new)
A a. Whereas it is of outmost importance to prevent shortages of medicines and, in case they occur, mitigate their consequences;
Amendment 91 #
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3 a. Highlights the need for a joint, pan-European, coordinated approach in introducing measures to tackle root causes of medicinal shortages, as ad-hoc solutions such as stock piling requirements could contribute to increased disparities between Member States given the low manufacturing capacity of the EU and economic differences between Member States;
Amendment 102 #
Draft opinion
Paragraph 4
Paragraph 4
4. Encourages the Commission to propose measures, including financial incentives and targeted guidelines on public procurements, to promote green manufacturing, within the EU, of strategically important chemicals used in medicine production, particularly APIs and intermediates; 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; notes that currently SMEs suffer, in particular, from disproportionate costs stemming from inefficient mechanisms of implementation of regulations;
Amendment 111 #
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4 a. Calls on the Commission to optimise regulatory processes, whilst maintaining its high scientific standards, in order to enable simplified administrative tasks associated with “variations”, improved access to information for patients and health care professionals, and simplified flow of medicines from one Member State to another in case of a shortage;