26 Amendments of Lynn BOYLAN related to 2016/2057(INI)
Amendment 2 #
Draft opinion
Recital A
Recital A
Amendment 7 #
Draft opinion
Recital A a (new)
Recital A a (new)
Aa. Calls for universal access to quality healthcare in Member States; believes this to be a fundamental right of European citizens; further believes this to be the only way to ensure equality in healthcare for citizens in all European Union Member States.
Amendment 9 #
Draft opinion
Recital B
Recital B
Amendment 16 #
Draft opinion
Recital C
Recital C
C. whereas the EU will need to oversee improvements in a range of fields that have an impact on how medicines are produced and distributed; calls on the Member States to support research and development (R&D) that focuses on the medical needs of all citizens, through ensuring that the structure for funding the research, development and commercialisation of new medicines is redirected towards the public good and to guarantee affordable and non- discriminatory access to medical advances, examining options such as bulk buying, risk sharing, and state funding of R&D; also calls on Member States to particularly focus on R&D to tackle antimicrobial resistance;
Amendment 16 #
Motion for a resolution
Citation 5 a (new)
Citation 5 a (new)
- having regard to the September 2016 United Nations Secretary-General's High-Level Panel on Access to Medicines Report on Promoting Innovation and Access to Health Technologies
Amendment 29 #
Draft opinion
Paragraph 2
Paragraph 2
Amendment 36 #
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Deplores the fact that there are 18 million people across the EU without access to health care; finds it unacceptable that there are 25 000 annual deaths in the EU due to lack of effective antibiotics; also finds it alarming that in a period of prosperity with many advances in healthcare, medicines and technology, there appears to be very little advancement in creating sustainable solutions for those without healthcare or medicines;
Amendment 42 #
Motion for a resolution
Recital B
Recital B
B. whereas public health systems are crucial to guarantee universal access to health care; believes this to be a fundamental right of European citizens; further believes this to be the only way to ensure equality in healthcare for citizens in all European Union Member States.
Amendment 57 #
Draft opinion
Paragraph 4
Paragraph 4
4. Recommends that information sharing and the training of medical professionals be made an immediate priority; highlights the negative impact that Member States' austerity policies and budgetary cuts have had on citizens access to healthcare and access to medicines; condemns the situation which has been fostered in healthcare systems whereby the value of a life is equated to wealth, whereby those who are financially better off can get quicker and better treatment than those lesser off;
Amendment 64 #
Draft opinion
Paragraph 5
Paragraph 5
5. Urges that universal access to medicines should not be contingent on price, which should reflect a fair balance between the cost of research, industry growth and the need for sustainable welfare systems; sees patent rights as an obstacle to access to medicines, and urges public policy makers to take definitive steps towards addressing issues arising around patent rights; calls for greater transparency in public procurement prices for medicines;
Amendment 72 #
Draft opinion
Paragraph 6
Paragraph 6
6. Reiterates that the stability of European welfare systems, which are one of the cornerstones of EU cooperation and whose budgets differ greatly from one Member State to another, is contingent on people being in employment, and that high levels of unemployment are making it essential to find new means of funding welfare; condemns the transforming of health as an inherent right for all people, to a market based commodity that is subject to cost and profiteering which creates a social divide by promoting differential treatment based on a patient's ability to pay;
Amendment 79 #
Draft opinion
Paragraph 7
Paragraph 7
Amendment 107 #
Motion for a resolution
Recital F
Recital F
F. whereas the Commission has had to introduce incentives to promote research in areas such as rare diseases, and whereas 25 000 people die each year in the EU owing to lack of access to adequate antimicrobial drugs; whereas drug-resistant diseases could cause 10 million deaths per annum worldwide by 2050
Amendment 147 #
Motion for a resolution
Recital J a (new)
Recital J a (new)
Ja. whereas the European Medicines Agency launched a pilot project in 2014 known as 'adaptive pathways' which sought to provide access for patients to new medicines, by gathering evidence through real-life use to supplement clinical trials
Amendment 152 #
Motion for a resolution
Recital J b (new)
Recital J b (new)
Jb. whereas people living with disabilities, as well as those with long term illnesses that are not life threatening but do hamper and hinder quality of life and make everyday living more difficult than for a person in full health, are the most vulnerable and need medicines the most;
Amendment 178 #
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Deplores the fact that there are 18 million people across the EU without access to health care; also finds it alarming that in a period of relative prosperity with many advances in healthcare, medicines and technology, there appears to be very little advancement in creating sustainable solutions for those without healthcare or medicines;
Amendment 184 #
Motion for a resolution
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Points outs that although pharmaceutical companies often argue that their R+D costs are prohibitively expensive, data shows that these companies' spend on marketing actually far outstrips R+D costs
Amendment 211 #
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Stresses that the fast-tracking of medicines and the circumvention of the standard risk assessment for licensing a medicine should not become the norm and must be restricted to only a very select number of medicines, for which an objective need must be clearly met. Calls therefore on the European Commission and the European Medicines Agency to precisely define unclear terms upon which the adaptive pathways mechanism is based such as 'unmet medical need'
Amendment 216 #
Motion for a resolution
Paragraph 4 b (new)
Paragraph 4 b (new)
4b. Notes with concern that 5% of all hospital admissions in the EU are due to an adverse drug reaction (ADR) and ADRs are the 5th leading cause of hospital death
Amendment 217 #
Motion for a resolution
Paragraph 4 c (new)
Paragraph 4 c (new)
4c. Highlights the concern expressed by healthcare professionals, civil society organisations and regulators that adaptive pathways which rely on limited preliminary clinical data, surrogate outcomes and observational studies risk incorrect conclusions on the benefit-harm of new drugs; regrets the approach of the EMA in this regard
Amendment 218 #
Motion for a resolution
Paragraph 4 d (new)
Paragraph 4 d (new)
4d. Notes with concern that a central element of the adaptive pathways mechanism is reliance upon 'real world data' i.e. observational data instead of data gathered during clinical trials
Amendment 336 #
Motion for a resolution
Paragraph 14
Paragraph 14
14. WelcomNotes initiatives such as the Innovative Medicines Initiative (IMI), but regrets that only a few of them are entirely public;
Amendment 341 #
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14a. Highlights with concern that IMI projects have been perceived as replicating work which individual companies would have had to undertake anyway, thereby subsidising private companies with EU money; calls on the Commission in this regard to ensure that IMI projects deliver real added-value for EU citizens
Amendment 343 #
Motion for a resolution
Paragraph 14 b (new)
Paragraph 14 b (new)
14b. Calls on the EU, as a public funder of research, to require that knowledge generated from such research is made freely and widely available through publication and online access;
Amendment 352 #
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Highlights the negative impact that Member States' austerity policies and budgetary cuts have had on citizens access to healthcare and access to medicines; condemns the situation which has been fostered in healthcare systems whereby the value of a life is equated to wealth, whereby those who are financially better off can receive faster and better quality treatment than those on lower incomes;
Amendment 362 #
Motion for a resolution
Paragraph 16 b (new)
Paragraph 16 b (new)
16b. Condemns the transforming of health as an inherent right for all people, to a market based commodity that is subject to cost and profiteering which creates a social divide by promoting differential treatment based on a patient's ability to pay;