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[Evaluation] European Parliament hearing - Elzbieta Bienkowska European Commissioner-designate for Internal Market, Industry, Entrepreneurship and SMEs


“Placing pharma policy in DG Enterprise was justified. It has traditionally been in DG Enterprise, but was moved to DG Sanco and has once again been instated as an Enterprise competence” said during her hearing Commissioner-designate Elzbieta Bienkowska. By Dorota Sienkiewicz,Health Equity and Policy Coherence Coordinator, and Martyna Giedrojć, EPHA Policy Officer for Health Systems The pharmaceutical industry is the biggest sector in the world. In terms of production, (...)
03/10/2014

Elżbieta Bieńkowska » European Commissioner for Internal Market, Industry, Entrepreneurship and SMEs


Elżbieta Bieńkowska (born on 4 February 1964 in Katowice, Poland) became the Minister of Regional Development in the Cabinet of the Prime Minister Donald Tusk between 2007 and 2013 in Poland. She was then appointed a Deputy Prime Minister and carried out her mandate at the Ministry of Infrastructure and Development. In 2014 she has been nominated by the Polish government for European Commissioner who has received the Internal Market, Industry, Entrepreneurship and SMEs portfolio (...)
01/10/2014

[EPHA Report] The sixty-seventh World Health Assembly (WHA)


From 19 to 24 May 2014, the Sixty-seventh session of the World Health Assembly (WHA) took place in Geneva. The WHA is the supreme decision-making body of World Health Organization (WHO). It determines the policies of the WHO, appoints its Director-General, supervises the organisation’s financial policies, and reviews and approves the proposed programme budget. The WHA is attended by delegations from all WHO Member States and focuses on a specific health agenda prepared by the (...)
06/06/2014

[European Commission report] Personalised Medicine


The European Commission has recently published a Staff Working Document (SWD) exploring the potential of Personalised Medicine, reporting on recent developments in the EU legislation, as well as looking at the factors affecting the uptake of personalised medicine in healthcare systems. Personalised Medicine is now more close to be effective to patients, which means that treatments can be designed taking into account a specific patient group and hence able to tackle the problem with the (...)
18/11/2013

The European Medicines Agency (EMA) publishes list of drugs under additional monitoring


As one of the deliverables of the pharmacovigilance legislation, that came into effect in July 2012, the European Medicines Agency (EMA) released an initial list of drugs subject to additional monitoring on 25 April 2013. Please click here to read the full EMA Press Release, which contains additional information. How to identify them? Medicines subject to additional monitoring will have to display an inverted back triangle in their package leaflet and in the information for healthcare (...)
25/04/2013

Clinical trials: Exploring the limits of transparency


Glenis Willmott MEP (S&D, UK) took the initiative to bring together experts to discuss the extent to which more transparency could be workable in non-commercial clinical trials. The debate, which took place in the European Parliament on 10 April, served to present the key arguments for and against increased transparency in the context of administrative and data reporting requirements for academic researchers and patient safety. EPHA’s Position on Clinical Trials urges political (...)
25/04/2013

European Medicines Agency Workshop on Medication Errors


The European Medicines Agency (EMA) organised a workshop on Medication Errors on 28 February – 1 March, a timely event given that such incidents are much more frequent across Europe than is commonly known. They are the most common preventable cause of adverse events in medication practice. The workshop was opened by EMA Director Guido Rasi who stated that, although the reporting of suspected adverse drug reactions to the EMA-administered EudraVigilance database forms an integral part (...)
27/03/2013

2013 PCWP/HCPs meetings at European Medicines Agency


EPHA is a member of the European Medicines Agency’s (EMA) Patients’ and Consumers’ Working Party and the Stakeholder Forum on Pharmacovigilance. Please find below information on the relevant meetings in 2013. Joint PCWP / HCPWP meeting 27-28 Feb 2013 Between 27-28 February, a joint Patients/Consumers Working Party and Healthcare Professionals Working Group meeting took place at the EMA in London. On day 1, the group discussed, among other things, the progress made in (...)
01/03/2013

European Parliament adopts draft proposal on Medicines Pricing directive


On February 6, the European Parliament voted on a draft report about a proposal relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems. The report was adopted in the parliamentarian plenary with 559 votes in favor, 54 against and 72 abstentions. As EPHA published this week, “Members of the European Parliament (MEPs) have been demanding more transparency on medicine (...)
07/02/2013

MEPs demand more transparency on medicine pricing


More transparency was demanded by MEPs at the last ENVI meeting on 18 December 2012 concerning the time limits for decision-making on pricing and reimbursement of medicines to ensure and improve access of patients to new medicines. MEPs recommended a 60-day time limit to decide on the pricing and reimbursement of generic medicines. Concerning new medicines, products will have to respect the current timeline of 180 days. A substantial number of amendments were adopted as demonstrated in the (...)
04/02/2013