38 Amendments of Mairead McGUINNESS related to 2020/2071(INI)
Amendment 11 #
Motion for a resolution
Citation 15 a (new)
Citation 15 a (new)
- having regard to the Commission communication of 20 May 2020 on the EU Biodiversity Strategy for 2030,
Amendment 25 #
Motion for a resolution
Recital A
Recital A
A. whereas thean increase in global demand has aggravatedcontributed to shortages of medicines in the EU, undermining; whereas shortages are also the result of a range of safety, quality, logistics and demand factors, including prior to the COVID-19 pandemic; whereas shortages undermine health services in the Member States and exposinge patients to considerable risks; whereas the Member States have a duty to find swift and effective solutions, including through closerommon European integrationcoordination and action; whereas shortages of medicines are also a global problem;
Amendment 38 #
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas there are important lessons to be learned from experiences during the COVID-19 pandemic; whereas some shortages resulted from restrictions imposed by other countries and an increased global demand; whereas shortages of some medicines in the intensive care setting resulted from significant unanticipated increased demand and issues at manufacturing sites within Europe, alongside restrictions on movement at EU internal borders, with imports from outside the EU in some cases helping to address shortages; whereas some Member States experienced issues relating to available stocks being in the wrong location at the wrong time, nationally and across the EU, rather than shortages of the medicines in question;
Amendment 45 #
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas medicine shortages are a growing public health threat with a serious impact on health care systems and public health;
Amendment 85 #
Motion for a resolution
Recital C
Recital C
C. whereas the loss of European sovereignty and independence in the health sector is linked toEU has experienced the relocation of production, with 40% of medicinal end products marketed in the EU now originating in third countries; whereas tche only way to save money is toaper production relyies heavily on subcontractors to produce pharmaceutical raw materials in Asia, where labour costs and environmental standards are lower, with the result that 80% of active ingredients are manufactured outside the EU, mainly in China and India;
Amendment 95 #
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas the EU continues to have a strong pharmaceutical manufacturing sector, particularly in the innovative sector, and is the world's largest exporter of pharmaceutical products, part of a global trade in pharmaceuticals; whereas the supply of generic medicines at a lower cost involving manufacturing outside the EU enables the affordability of medicines, impacting Member State healthcare budgets and patients' access;
Amendment 109 #
Motion for a resolution
Recital D
Recital D
D. whereas the consequence of growing demand coupled with price suppression is theproduction of active ingredients has seen a concentration of supply, a reduction in the number of chemicals manufacturers and a lack of alternative solutions should problems arise;
Amendment 139 #
Motion for a resolution
Recital F
Recital F
F. whereas there are no price harmonisation arrangements to facilitate ‘parallel exports’ to countries where theparallel trade results from different price levels for medicines in question is more expensivedifferent Member States;
Amendment 156 #
Motion for a resolution
Recital G
Recital G
G. whereas, in the absence of a regulatory authority, stockpiling in some Member States iscan leading to a market imbalanceshortages in other Member States;
Amendment 157 #
Motion for a resolution
Recital G
Recital G
G. whereas, in the absence of a regulatory authority, stockpiling in some Member States is leading to a market imbalance excessive stockpiling can lead to a market imbalance if cooperation between Member States is insufficient;
Amendment 174 #
Motion for a resolution
Recital I
Recital I
I. whereas the greater number, geographical spread and impact of epidemics is partly attributable to climate change, in combination with globalisation, urbanisation and increased travel;
Amendment 178 #
Motion for a resolution
Recital J
Recital J
J. whereas the destruction of biodiversity, the illegal trade in wildlife, the proliferation of man-made habitats and damage to natural areas densely populated by humans are facilitating the propagation of zoonoses, i.e. the transmission to humans and rapid spread of animal pathogens; whereas biodiversity is an important source for existing medicines and potential future drug development;
Amendment 187 #
Motion for a resolution
Recital J a (new)
Recital J a (new)
Ja. whereas a strong, innovative and competitive pharmaceutical industry in Europe is in the vital interest of the EU and its Member States;
Amendment 190 #
Motion for a resolution
Recital J b (new)
Recital J b (new)
Jb. whereas the pharmaceutical industry needs the right legal framework to do research, development and production of pharmaceuticals within the EU;
Amendment 194 #
Motion for a resolution
Paragraph 1
Paragraph 1
1. Stresses the geostrategic imperative that the Union pregain its sovereignty and independence with regard to health care and secure its supply of medicines and medical equipmvent shortages of medicines, medical equipment and medical devices for the benefit of patients;
Amendment 215 #
Motion for a resolution
Paragraph 2
Paragraph 2
2. Points out that, while public healthcare policies are a Member State matter, it is incumbent upon the EU tocompetence, the EU can and must coordinate and complement national measures; notes that the COVID-19 pandemic has demonstrated the need to guarantee affordable and high-quality health services for European citizens; recognises the pressure that the COVID-19 pandemic has put on Member State healthcare budgets;
Amendment 243 #
Motion for a resolution
Paragraph 3
Paragraph 3
3. Stresses the need for health policies to focus on patients’ interests and for closer cooperation between Member States; highlights the potential harm to patients from shortages of medicines and medical devices;
Amendment 268 #
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls on the Commission and the Member States to take whatever action is needed to restore Europeato undertake a detailed analysis of the causes of shortages of medicines which should report before the end of the year, to inform policy responses; calls on thealth sovereignty and local pharmaceutical manufacturing, giving priority to essential and strategic medicines; calls on the Commission to map out potential production sites in the EU Commission to undertake an impact assessment to gather data on and review approaches to active substance production and supply, including the possible role of increased production in the EU, to diversify and complement the supply from third countries; welcomes that the Commission’s upcoming Pharmacy Strategy will be based on availability, affordability, sustainability and security of supply, and calls for particular attention to the issue of shortages;
Amendment 312 #
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls on the Commission to address in its next pharmaceutical and industrial strategies issues relating to the availability and accessibility of medicines and manufacturers’ dependence on third countries; calls on the Commission to address these issues also in the context of the forthcoming review of trade policy and at the WTO, where the EU should take a strong leadership role;
Amendment 333 #
Motion for a resolution
Paragraph 6
Paragraph 6
6. Urges the Commission and the Member States to introduce tax and financial incentiEmphasises the strategic significance of this sector and the importance of inves tin return for appropriate commitments and to authorise state aid to encourage producers to locate their operations in Europe, from compound manufacturing to packaging and distribution; emphasises the strategic significance of this sector and the importance of investing in European companies, ig in European companies, in the interests of resource diversification; calls on the EU to work on global supply chain quality and integrity, collaborating with non-EEA jurisdictions including at the WTO, which should include an emphasis on the interhighests of resource diversificationlabour and environmental standards in production worldwide;
Amendment 384 #
Motion for a resolution
Paragraph 7
Paragraph 7
7. Notes that security of supply is an essential factor in combating shortages and must be used as a qualitative criterion in connection with the award of public pharmacy contracts and calls for tender for the supply of medicines, as recommended in Article 67 of Directive 2014/24/EU; proposes that investments in the manufacture of active ingredients and medicinal end products in the EUa resilient supply chain should also be a criterion;
Amendment 423 #
Motion for a resolution
Paragraph 9
Paragraph 9
9. Calls on the Commission and the Member States to to make concreate one or more European non-profitproposals how models of public private pharmaceutical undertakings which operate in the public interest to manufacture priority medicines of strategic importance for health caretnership like the US Biomedical Advanced Research and Development Authority can be established in the EU to operate in the public interest; stresses the key contribution that can be made by new technologies and artificial intelligence in enabling European laboratory researchers to form networks and share their objectives and findings;
Amendment 433 #
Motion for a resolution
Paragraph 9
Paragraph 9
9. Calls on the Commission and the Member States to examine the possibility of createing one or more European non- profit pharmaceutical undertakings which operate in the public interest to manufacture priority medicines of strategic importance for health care; stresses the key contribution that can be made by new technologies and artificial intelligence in enabling European laboratory researchers to form networks and share their objectives and findings;
Amendment 444 #
Motion for a resolution
Paragraph 10
Paragraph 10
10. Calls for links to be establishncouraged between the pharmaceutical industry and other production sectors, such as farmingagriculture, horticulture and forestry, in a bid to develop the production of active ingredients in the EU; calls for efforts to counter over-specialisation in certain sectors and for substantial investment in research, the bioeconomy and biotechnology, for the purposes of resource diversification;
Amendment 448 #
Motion for a resolution
Paragraph 11
Paragraph 11
11. Stresses the importance of research and innovation, and calls for the establishment of a genuine European network, given that the price of relocation must not be a deterioration in the quality of medicals part of a European eco- system for the production of medicines; highlights the value of global collaboration in research;
Amendment 468 #
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Notes the impact on the supply of medicines of the UK's withdrawal from the EU, particularly for Ireland, and calls for targeted actions to ensure continued and rapid access to safe medicines and medical devices for patients, including a secure and consistent supply of radioisotopes;
Amendment 489 #
Motion for a resolution
Paragraph 12
Paragraph 12
12. Recommends the introduction of centralised managementat the Commission and the EMA work with Member States and the industry to bring about greater transparency in the distribution chain and the creation of; recommends that the Commission creates a European supply management unit tasked with developing a European strategy to prevent and resolve breaks in supply;
Amendment 529 #
Motion for a resolution
Paragraph 13
Paragraph 13
13. Calls on the Commission to develop European health strategies on the basis of a common basket of drugs for the treatment of cancer and infections whose prices are harmonised, in a bid to counter recurrent shortages and ensure that patients have access to treatment; calls on the Commission to also examine, whether a harmonised price for those drugs may solve the problems of shortages for those life-saving drugs;
Amendment 535 #
Motion for a resolution
Paragraph 13
Paragraph 13
13. Calls on the Commission to develop European health strategies on the basis of a common basket of drugs for the treatment of cancer and infections whose prices are harmonised, taking account of differences in clinical approach across the Member States, in a bid to counter recurrent shortages and ensure that patients have access to treatment;
Amendment 550 #
Motion for a resolution
Paragraph 14
Paragraph 14
14. Calls on the Commission to create a European contingency reserve of medicines of strategic importance for health care, taking account of differences in clinical approach across the Member States, supplies of which are critical, along the lines of the ‘RescEU’ mechanism, in order to alleviate shortages outside crisis periods;
Amendment 572 #
Motion for a resolution
Paragraph 15
Paragraph 15
15. Calls on the Commission and the Member States to adopt a joint definition of ‘medicines of strategic importance for health care’ and of ‘criticality’, emphasising the value of these medicines for public health, the lack of alternatives and the vulnerability of the production chain; calls for a European regulatory authority to be designated to carry out the task of setting quotas for theensure the fair and transparent allocation of medicines from that reserve to the Member States;
Amendment 614 #
Motion for a resolution
Paragraph 17
Paragraph 17
17. Calls for further invitations to tender to be issued at European level in an effort to counter shortages, as has been done following the onset of the COVID-19 virus, with simplified procedures in the interests of improved response times; notes the potential for Member States, in particular smaller Member States, to use joint procurement to address affordability as a cause of shortages;
Amendment 625 #
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Calls on the Commission and the EMA to work with industry to ensure that medicines made available in one Member State are available in all other Member States, in particular smaller Member States;
Amendment 650 #
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls on the Commission to set up an innovative centralised digital platform for sharing information provided by national agencies and all stakeholders regarding demand for and shortages of medicines and medical equipment; welcomes the work of the joint EMA- HMA taskforce on the availability of medicines and introduction by the EMA of the SPOC and i-SPOC systems; calls for existing information systems to be improved so as to provide a clear overview of demand, problems, shortages and requirements in each Member State, with a view to preventing stockpiling and anticipating shortages before they occur;
Amendment 675 #
Motion for a resolution
Paragraph 19
Paragraph 19
19. Considers it essential to improve communication with healthcare professionals and patientsdata on medicine availability through the use of innovative digital tools providing as close as possible to real-time data on the availability, location, quantity and price of a given medicine, in compliance with data protection legislation; notes the benefits that this would bring not only to healthcare professionals and patients, but also to Member States' authorities and the EMA as they monitor demand, availability and shortages;
Amendment 699 #
Motion for a resolution
Paragraph 20
Paragraph 20
20. Calls for an electronic information notice to be drawn up in all the Union languages for every medicine on the EU market, in order to facilitate sales of medicines between Member States; recommends the provision of more comprehensive information on the origin of medicines;
Amendment 719 #
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21a. Welcomes the Commission’s Guidelines on the optimal and rational supply of medicines to avoid shortages during the COVID-19 outbreak, and suggests building on its concepts; calls on actors in the supply chain to monitor their stocks and production capacity, share information with authorities, report shortages and monitor any potential disruptions in the supply of medicines, including early notification for predictable shortages; calls on the EMA to coordinate joint industry efforts to find effective measures and resources to reduce shortages and meet the demand for medicines;
Amendment 732 #
Motion for a resolution
Paragraph 22
Paragraph 22
22. Takes the view that the introduction of stress tests to assess the resilience of health systems in emergencies wcould provide an effective means of counteringhelp identify structural risk factors which lead to shortages , assisting the event of pandemics and of identifying structural risk factors which go to create shortageffort to counter shortages including in the event of pandemics;