Pharmaceuticals and Medicines

EMA reflection paper discusses globalisation of clinical trials

The European Medicines Agency (EMA) has published the final reflection paper on ethical and good clinical practice aspects of clinical trials of medicinal products for human use. Conducted outside of the EU/EEA and submitted in marketing authorisation, it produced several applications to the EU regulatory authorities. Entering into force on 1 May 2012, the EMA reflection paper aims to strengthen existing processes to provide assurance to regulators and stakeholders that clinical trials (...)

Save the Date - 2012 ESWI Flu Summit

On 23 May 2012, the second edition of the European Scientific Working Group on Influenza’s (ESWI) European Influenza Summit will be held at the Albert Hall Complex in Brussels. The aim of this one-day free of charge meeting will be to provide all influenza partners with an informal platform to exchange good practices and to initiate concrete actions to improve public health protection against influenza. Please visit www.flusummit.org regularly to stay informed of all developments in (...)

EPHA Briefing on Antimicrobial Resistance

Antimicrobial resistance (AMR) has been described as one of the biggest threats to public health - a worrisome development since resistance to drugs designed to treat severe diseases is becoming more widespread. EPHA’s briefing describes the causes of AMR; evaluates what is being done at an EU and international level; and explores some of challenges faced today by public health. EPHA Briefing on AMR The increasing spread of AMR coupled with ineffective policies to counteract it, (...)

Civil society call for greater public return on EU health R&D spending and a turn to needs-driven innovation

HAI Europe, EPHA member, and TACD (Trans-Atlantic Consumer Dialogue) launched their new Policy Paper. The report is entitled ’Time for the EU to lead on innovation: EU policy opportunities in biomedical innovation and the creation of public knowledge goods today.’ The paper is a call for EU-funded research and development to open needs-driven innovation to support affordable access to biomedical knowledge and public goods. Read HAI and TACD paper: Time for the EU to lead on (...)

The new PGEU Annual Report 2011: 24 hours in the pharmacy

PGEU - EPHA member published its 2011 annual report. The 2011 Annual report aims to present an overview of the activities, objectives and achievements during the year 2011 based on 24 hours typical of a pharmacy. It covers three major areas in this report: Legislation: Pharmacovigilance; Information to patients; Falsified medicines; Cross-border Recognition of Prescriptions; The Directive on the Recognition of Professional Qualifications. Infringement Proceedings Professional (...)

Dalli calls for meeting patients’ needs in revision of Clinical Trials Directive

On 7 March 2012, European Commissioner for Health and Consumer Policy John Dalli delivered a speech entitled ’’Clinical Trials Directive - meeting patients’ needs’’ to put the revision of the Clinical Trials Directive in the wider policy perspective of the EU. The current Clinical Trial Directive (CTD) rules are over 10 years old and much criticised as they have led to an increase in costs and administrative burden. In his speech, Commissioner Dalli expressed (...)

Antitrust: Commission closes AstraZeneca and Nycomed investigations

On 1 March 2012, the European Commission has ceased its investigation of the pharmaceutical companies AstraZeneca and Nycomed. This research was based on a suspicion of individual or joint activity to delay the market entry of generic drugs. This activity would have been contrary to EU antitrust rules that prohibit restrictive business practices and the abuse of a dominant market position, as per Articles 101 and 102 of the Lisbon Treaty. The Commission has been investigating the (...)

Faster reimbursement of medicines in the EU in the future

On 1 March 2012, the European Commission presented a proposal to speed up the market entry of new medicines. The proposal establishes deadlines for decisions on matters of medicines pricing and reimbursement. Meeting these deadlines is subject to stringent control measures. The new draft Directive represents an important simplification measure and revokes the previous Transparency Directive dating back to 1989, which no longer reflected the increased complexity of pricing and reimbursement (...)

2012 EMA PCWP Meetings & Stakeholders Forum

EPHA was amongst the participants of the first 2012 meeting of the European Medicines Agency’s Patients and Consumers Working Party (PCWP) on 28 February 2012, following the Fourth Stakeholders Forum on Pharmacovigilance on the previous day. PCWP Meeting The PCWP/Health Professionals Working Group joint meeting on 28 February covered various topics including communication and information (e.g., Q&A on biosimilar medicines; public webpage on the summary of product characteristics (...)

Getting drugs online: Illegal online pharmacies target young people

The International Narcotics Control Board published its Annual report 2011 in which it warns that an increasing number of illegal Internet pharmacies in the world target young audiences via social media - increasing risks of long-term addiction to medicines. The International Narcotics Control Board has chosen to highlight this new trend as national and international regulations find it difficult to address the issue so far. The Annual report 2011 points out that illicit drugs or (...)