Pharmaceuticals and Medicines
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Brussels, 17 May – In a seminar hosted yesterday by the Group of the Progressive Alliance of Socialists & Democrats (S&D) in the European Parliament and the Member of the European Parliament (MEP) Alejandro Cercas (S&D, Spain), six MEPs from various political groups (1) along with representatives of governments, leading academics, researches and public health organisations (2) met to raise awareness about one of the most alarming issues that European healthcare systems (...)
When discussing the topic of access to medicines in the context of the economic crisis we have to consider three determinants: affordability and availability, in terms of access to medicines, and innovation in terms of developing new methods of assuring best possible health outcomes.
Usually, health expenditures are mostly covered by public funding and supplemented by private spending. The economic crisis has forced public expending to be cut making patient co-payment (...)
Clinical trials are “Investigations in humans intended to discover or verify the effects of one or more investigational medicinal products (IMPs)”. Trials conducted in the European Union (EU) are currently governed by Directive 2001/20/EC (the Clinical Trials Directive, CTD) but these guidelines have been implemented differently across member states, thereby failing to reduce red tape and increasing costs. Consequently, in July 2012, the Commission published its (...)
This high level meeting revolved around various political processes linked to the economic crisis. Some of the topics discussed include implementation of the Europe 2020 strategy, as well as pharmaceutical legislation for ensuring that people living in Europe have access to a wide range of quality and affordable medicines.
The meeting hosted by Mr Alejandro Cercas, MEP (Spain,S&D) and by the Socialists and Democrats in the European Parliament (S&D Group) served to assess the impact (...)
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 (...)
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 (...)
Health Rights and Patients
On 18 April, the European Parliament (EP) voted on a Resolution on the impact of the financial and economic crisis on human rights. The resolution highlighted some of the global impacts of the crisis on the right to health. EPHA applauds the EP’s recognition of the multiple impacts of the crisis on ordinary people and the need to further champion public health across Europe.
The Resolution states that "the rising price of medicines (by up to 30%) is having a negative impact on the (...)
The third annual Flu Summit organised by EPHA member the European Scientific Working Group on Influenza will take place on 2 May 2013 in Brussels. It will be an opportunity to learn about and discuss with experts issues such as pandemic preparedness, new influenza target groups, and vaccination strategies.
This year’s edition focuses on new developments and challenges in the influenza field, with special attention for discussions on safety and effectiveness of influenza vaccines. (...)
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 (...)
The European Parliament voted on its plenary session on 13 March on the reform of the common agricultural policy (CAP). As part of this vote, amendments concerning Antimicrobial Resistance (AMR) were offered and adopted as part of the Parliament’s position for the second reading procedure.
The relation between AMR and the Common Agricultural Policy (CAP)
The adopted amendment 192 and 193 introduces a new Good Agricultural and Environmental Condition (GAEC) standard (containing a (...)