29 Amendments of Kateřina KONEČNÁ related to 2016/2057(INI)
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 51 #
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas pharmaceuticals are one of the main pillars of healthcare rather than mere objects of trade;
Amendment 88 #
Motion for a resolution
Recital E
Recital E
E. whereas the aim of intellectual property is to benefit society, guaranteeing investment returns to and promote innovation, and whereas there is concern about the abuse/misuse thereof; notes the Council Conclusions of 17 June 2016 inviting the Commission to conduct an evidence-based analysis on the overall impact of IP in promoting innovation;
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 203 #
Motion for a resolution
Paragraph 4
Paragraph 4
4. Stresses that the interests of the pharmaceutical industry favour short trials and fast access to the market, especially in case of unmet needs, the interests of patients favour more efficient trials and fast access to safe and effective medicines;
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 314 #
Motion for a resolution
Paragraph 13
Paragraph 13
13. Believes that a fair price should cover the cost of the drug development and production, plus a margin of profitprices of medicines should be adequate to the specific economic situation of the country where they are marketed;
Amendment 320 #
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. Stresses the importance of transparency across the field (including as regards clinical data, R&D costs and public funding, marketing strategies, actual prices and reimbursement levels) to improve access to medicines with additional patient and health system relevant benefits;
Amendment 337 #
Motion for a resolution
Paragraph 14
Paragraph 14
14. Welcomes initiatives such as the Innovative Medicines Initiative (IMI), but regrets that only a few of them are entirely public; Recognises that pharmaceutical innovation is driven by both public and private investments in a complementary manner, and private investors carry the high risk of failure in the development stage;
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 347 #
Motion for a resolution
Paragraph 16
Paragraph 16
16. Highlights the European procedure for joint procurement of medicines used for the acquisition of vaccines in accordance with Decision No 1082/2013/EU; encourages the possible use of the procedure in case of shortages of infant vaccines;
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;
Amendment 369 #
Motion for a resolution
Paragraph 17
Paragraph 17
17. Calls for EU-wide measures to guarantee the right of patients to universal, affordable, effective, safe and timely access to essential and innovative therapies, and to guarantee the sustainability of EU public health care systems, and to ensure future investment in pharmaceutical innovation;
Amendment 402 #
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19a. Calls on the European Commission to promote EMA's initiative on the safe use of adaptive pathways where it is deemed appropriate, to reduce the time to bring to the market medicines that address unmet medical needs and to ensure that marketing authorization will be granted without compromising patient safety, and only if there is a positive balance of benefits and risks for a defined patient population;
Amendment 419 #
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Calls on the Commission to adopt a targeted SPC manufacturing waiver for export purposes to allow EU-based manufacturers of generic and biosimilar medicines to compete on equal footing with competitors from non-EU countries, thus avoiding the outsourcing of production and helping to maintain and create additional jobs and growth in the EU;
Amendment 450 #
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22a. Calls on the Commission to analyse the adequacy of the legislative framework to the current situation with the parallel export and re-export of medicines, and underlines the need to strike the right balance between public health and economic considerations;
Amendment 482 #
Motion for a resolution
Paragraph 24 a (new)
Paragraph 24 a (new)
24a. Calls on the Commission to analyse the impact of the existing rules outlined in Directive 2001/83/EC governing the marketing authorisation procedures of non-prescription homeopathic medicinal products on patients' choice, therapeutic freedom and ultimately access to medicines intended at self-medication;
Amendment 485 #
Motion for a resolution
Paragraph 24 a (new)
Paragraph 24 a (new)
24a. Reiterates that European collaboration on HTA allows Member States to pool their expertise and use their resources more effectively, thus helping them to better meet the increasing demand for assessments;
Amendment 488 #
Motion for a resolution
Paragraph 24 b (new)
Paragraph 24 b (new)
24b. Calls on the European Commission to enhance dialogue on unmet medical needs between all relevant stakeholders, patients, healthcare professionals, regulators, HTA bodies, payers and developers throughout the life span of medicines.
Amendment 503 #
Motion for a resolution
Paragraph 25 a (new)
Paragraph 25 a (new)
25a. Calls on the Commission and the Member States to identify and/or develop frameworks, structures and methodologies in order to meaningfully incorporate patient evidence at all stages of the medicines R&D cycle, from early dialogue to regulatory approval, Health Technology Assessment, relative effectiveness assessments, and pricing and reimbursement decision-making with the involvement of patients and their representative organisations.
Amendment 542 #
Motion for a resolution
Paragraph 29
Paragraph 29
29. Calls on the Commission and the Council to explore new measures to control prices, such as horizontal scanningdevelop a framework for ensuring "fair access" that maximises patient access and societal benefit whilst avoiding unacceptable impact on healthcare budgets; including exploration of different measures, such as horizon scanning, early dialogue, innovative pricing models, mechanisms for systematic collection of real-world data, and coordinating joint procurements;
Amendment 570 #
Motion for a resolution
Paragraph 32 a (new)
Paragraph 32 a (new)
32a. Calls on the Commission to take note of the scale of the problem with parallel export of pharmaceuticals within the EU, as well as of the margin of discretion of the Member States when justifying measures on public health grounds;
Amendment 582 #
Motion for a resolution
Paragraph 34
Paragraph 34
34. Calls on the Commission to examine and compare the prices ofaccess to medicines in the EU and to present an annual report to Parliament in this regard;
Amendment 595 #
Motion for a resolution
Paragraph 36
Paragraph 36
36. Calls on the Commission to analyse the causes of shortages, to establish and update together with Member States, EMA and relevant stakeholders a list of essential medicines under short of supply and monitor compliance with Article 81 of Directive 2001/83/EU on shortages of supply, and to promote the supply of generics;
Amendment 597 #
Motion for a resolution
Paragraph 36
Paragraph 36
36. Calls on the Commission to analyse the causes of shortages, particularly the specific impact of parallel trade of medicines, to establish a list of essential medicines and monitor compliance with Article 81 of Directive 2001/83/EU on shortages of supply, and to promote the supply of generics;