Activities of Elżbieta Katarzyna ŁUKACIJEWSKA 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
Recital A
A. whereas the problem of medicinthe shortage of medicines in the Member States is getting ever more severe on account of the lack of production capacity in the EU and the relocation of our industries in the sector to other markets in third countriconstantly growing due to multifactorial reasons, such as economic causes, increasing regulatory and administrative burden, unforeseen surges in demand, supply chain interdependencies, transportation-related bottlenecks and manufacturing and quality challenges;
Amendment 16 #
Draft opinion
Recital C a (new)
Recital C a (new)
C a. whereas ensuring full patient access is one of the core objectives of the Union and the WHO, and one of the Sustainable Development Goals, and whereas patients rely on equitable and efficient access to medicines based on a sustainable, competitive, multi-source and well-functioning Single Market, including the Single European Transport Area;
Amendment 20 #
Draft opinion
Recital C b (new)
Recital C b (new)
C b. whereas the COVID-19 pandemic outbreak demonstrated the importance of coordination between EU policies and departments to promptly and efficiently react to emergencies as well as to prevent medicines shortages, and to mitigate them in case they occur;
Amendment 23 #
Draft opinion
Recital C c (new)
Recital C c (new)
C c. whereas the COVID-19 pandemic outbreak stressed that European coordination among EU Institutions, regulators and pharmaceutical supply chain experts is vital to respond in real- time to health crisis and to supply disruption, including shortages of medicines, in all relevant policy areas;
Amendment 25 #
Draft opinion
Recital C d (new)
Recital C d (new)
C d. whereas the COVID-19 pandemic outbreak exacerbated the existing situation, it emerged that the pharmaceutical supply chain is interconnected within EU Members States and externally, and relies heavily on fully and properly functioning Single European Transport Area;
Amendment 26 #
Draft opinion
Recital C e (new)
Recital C e (new)
C e. whereas the COVID-19 pandemic outbreak demonstrated the importance of prioritising the circulation of essential goods, such as medicines and medical goods, including their undisrupted flow between Member States;
Amendment 33 #
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1 a. Calls on the Commission to coordinate a pan-European response to medicines shortages in order to ensure equitable and sustainable access to medicines; believes that a coordinated EU response is of utmost importance to avoid spill-over effects of individual and uncoordinated national measures addressing local medicines shortages, and to ensure the patients' right to universal, equitable, affordable, effective, safe and timely access to essential medicines, as well as to guarantee the sustainability of the EU public healthcare systems; is of the opinion that this pan-European approach should focus on coordinating Member States' policy measures to address the root causes of medicines shortages;
Amendment 44 #
Draft opinion
Paragraph 3
Paragraph 3
3. Calls on the Member States to adopt a strategic plans to upgrade their existing infrastructure for an efficient supply of medicines; deems it necessary to remove bottlenecks, boost, and believes that it is necessary to remove all the existing bottlenecks, tackle existing obstacles to fully integrated and well functioning Single European Transport Area for all modes of transport, to boost the intermodality (whilest favouring the shift to rail), finance the main hubs (ports, airports and, intermodal platforms), and to enhance the delivery of various types of goods, including dangerous goodsones which are crucial for the production of the chemical and pharmaceutical industry;
Amendment 61 #
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. Calls on the Commission to support Member States, also financially, during emergency events, such as pandemic outbreaks, to give priority and ensure reserved space in all cargo to essential goods, such as medicines, active pharmaceutical ingredients, medical equipment, etc.;
Amendment 63 #
Draft opinion
Paragraph 5 b (new)
Paragraph 5 b (new)
5 b. calls for the efficiency enhancement of regulatory procedures and swift implementation of fast-track processes to timely mitigate the medicines shortage;
Amendment 73 #
Draft opinion
Paragraph 7
Paragraph 7
7. Notes that the COVID-19 outbreak has laid barpandemic outbreak made the weaknesses of the European production systemgoods circulation and transportation system during extraordinary circumstances visible, highlighting the importance of timely deliveringy of medicines swiftly in urgent and exceptional circumstances that could ariseoccur in the future.;
Amendment 79 #
Draft opinion
Paragraph 7 a (new)
Paragraph 7 a (new)
7 a. Calls on the Commission to immediately activate European and global cooperation during crisis events, to prioritise the intra-EU or extra-EU circulation of essential goods, such as medicines, active pharmaceutical ingredients, intermediates, key starting materials ingredients, etc., to maintain road, ports, rail, airport traffic flowing by creating priority “Green lanes” between Member States and between EU and relevant third countries, and within those countries, for these essential goods;
Amendment 84 #
Draft opinion
Paragraph 7 b (new)
Paragraph 7 b (new)
7 b. Emphasis the importance of implementing specific measures to maintain, first and foremost, fully functioning and healthy European multi- supplier market with the full enforcement of „Green lanes” for medicine products transportation, as well as facilitation of the fastest modes of transport to carry especially time sensitive cargo, such as medicines;
Amendment 89 #
Draft opinion
Paragraph 7 c (new)
Paragraph 7 c (new)
7 c. Calls on the Commission and the Member States to ensure that healthcare workers, including pharmaceutical employees, are authorised to cross internal borders if they work in a neighbouring country;