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Review of medicated feed legislation

21-06-2016

In 2014 the Commission presented a proposal for a regulation on medicated feed with the aim to update and harmonise rules which date from 1990. These rules are currently laid out in a directive, which would be repealed and replaced by a regulation. According to the Commission, the need to harmonise the production, marketing and use of medicated feed at EU level results from differences in national implementation that cause difficulties for producers and animal holders and create obstacles in the ...

In 2014 the Commission presented a proposal for a regulation on medicated feed with the aim to update and harmonise rules which date from 1990. These rules are currently laid out in a directive, which would be repealed and replaced by a regulation. According to the Commission, the need to harmonise the production, marketing and use of medicated feed at EU level results from differences in national implementation that cause difficulties for producers and animal holders and create obstacles in the single market. The revised provisions should also contribute to tackling the problem of antimicrobial resistance. Another aim would be to expand the scope of the regulation to pet animals to facilitate the availability of medicated feed for them. The legislation on medicated feed is strongly interrelated with the legislation on veterinary medicines. This proposal was therefore presented together with the draft regulation on veterinary medicinal products and legislative work on both acts is being coordinated to assure consistency between their provisions. On 15 March 2016, the Committee for Agriculture and Rural Development adopted its report on the proposal and decided to open interinstitutional negotiations.

ENVI Relevant Legislative Areas of the EU-US Trade and Investment Partnership Negotiations (TTIP)

05-02-2015

In February 2013, the European Union (EU) and the United States of America (US) started the procedures necessary for initiating formal negotiations on a free trade agreement, referred to as the “Transatlantic Trade and Investment Partnership” (TTIP). The first round of negotiations took place in Washington D.C. in July 2013, the seventh round ended on 3 October 2014 and the eight round is taking place in Brussels from 2 to 6 February 2015. In order to monitor the on-going negotiations, the Committee ...

In February 2013, the European Union (EU) and the United States of America (US) started the procedures necessary for initiating formal negotiations on a free trade agreement, referred to as the “Transatlantic Trade and Investment Partnership” (TTIP). The first round of negotiations took place in Washington D.C. in July 2013, the seventh round ended on 3 October 2014 and the eight round is taking place in Brussels from 2 to 6 February 2015. In order to monitor the on-going negotiations, the Committee on Environment, Public Health and Food Safety (ENVI) commissioned a study on "ENVI Relevant Legislative Areas of the EU-US Trade and Investment Partnership Negotiations (TTIP)". The study complemented a 2013 study on “Legal Implications of TTIP for the Acquis Communautaire in ENVI Relevant Sectors” for the ENVI Committee. This leaflet presents the key findings of the 2014 study.

Proceedings of the Workshop on "Effectiveness of Medicines and Therapies"

12-12-2013

This report summarises the presentations and discussions at the Workshop on “Effectiveness of Medicines and Therapies”, held at the European Parliament in Brussels, on Wednesday 18 September 2013. The aim of the workshop was to exchange views on the latest developments and main challenges healthcare systems have to address while assessing risks and benefits of new drugs and therapies. The workshop was hosted by MEP Mr Alojz PETERLE (EPP, SL), Co-chair of the Health Working Group within the ENVI Committee ...

This report summarises the presentations and discussions at the Workshop on “Effectiveness of Medicines and Therapies”, held at the European Parliament in Brussels, on Wednesday 18 September 2013. The aim of the workshop was to exchange views on the latest developments and main challenges healthcare systems have to address while assessing risks and benefits of new drugs and therapies. The workshop was hosted by MEP Mr Alojz PETERLE (EPP, SL), Co-chair of the Health Working Group within the ENVI Committee.

Külső szerző

Tapani PIHA (DG SANCO, European Commission), Francesco PIGNATTI (Haematology and Diagnostics at European Medicines Agency - EMA), Jonathan CYLUS (European Observatory on Health Systems and Policies, London, the UK), Erik BAARS (University of Applied Sciences, Leiden, the Netherlands), Lidija GAJSKI (Croatian Association for Patients' Rights, Zagreb, Croatia)

Annual report on competition policy

06-06-2013

The European Commission (EC) publishes annual reports on EU competition policy, covering the main developments and enforcement actions. The 2011 edition focused on the role of State aid policy in the resolution of financial crisis.

The European Commission (EC) publishes annual reports on EU competition policy, covering the main developments and enforcement actions. The 2011 edition focused on the role of State aid policy in the resolution of financial crisis.

Disease Mongering (Pseudo-Disease Promotion)

15-11-2012

Disease mongering is the promotion of pseudo-diseases by the pharmaceutical industry aiming at economic benefit. Medical equipment manufacturers, insurance companies, doctors or patient groups may also use it for monetary gain or influence. It has increased in parallel with society's 'medicalisation' and the growth of the pharmaceutical complex. Due to massive investments in marketing and lobbying, ample use of internet and media, and the emergence of new markets, it is becoming a matter of concern ...

Disease mongering is the promotion of pseudo-diseases by the pharmaceutical industry aiming at economic benefit. Medical equipment manufacturers, insurance companies, doctors or patient groups may also use it for monetary gain or influence. It has increased in parallel with society's 'medicalisation' and the growth of the pharmaceutical complex. Due to massive investments in marketing and lobbying, ample use of internet and media, and the emergence of new markets, it is becoming a matter of concern, and policy makers should be aware of its perils and consequences.

Clinical Trials in Developing Countries : How to Protect People Against Unethical Practices ?

27-03-2009

Executive summary European legislation regulating the marketing authorisation of medical products states that results from clinical trials that do not meet the ethical requirements of Good Clinical Practice, cannot legally be used by an applicant to justify its application, irrespective of whether the trial was done inside or outside the EU. However, earlier studies indicate that this legislation is not always properly observed: these studies identified trials with an unethical design that were part ...

Executive summary European legislation regulating the marketing authorisation of medical products states that results from clinical trials that do not meet the ethical requirements of Good Clinical Practice, cannot legally be used by an applicant to justify its application, irrespective of whether the trial was done inside or outside the EU. However, earlier studies indicate that this legislation is not always properly observed: these studies identified trials with an unethical design that were part of approved EU marketing applications. Clinical trials that are no longer accepted by Western European ethics committees are approved by the local ethics committees in countries like India, China, Argentina and Russia. Once officially approved by an ethics committee, there are no obstacles to including the trial in the technical dossier of a marketing application. In particular the ethical principles which are of utmost importance for developing countries, as reflected in the Declaration of Helsinki, are ignored by companies and regulatory authorities. The main objective of this paper is to provide the European Parliament with concrete recommendations, both at legislative and enforcement level, aimed to guarantee that trials conducted in third countries are done so in conformity with EU and international ethical standards. [...]

Külső szerző

Irene Schipper (SOMO - Center for Research on Multinational Companies, Amsterdam, Holland)

Impact of the Financial and Economic Crisis on European Industries - Compilation of Briefing Papers

05-03-2009

Compilation of briefing papers assessing the impacts of the financial and economic crisis on the automotive, chemical, pharmaceutical and food industries in the EU.

Compilation of briefing papers assessing the impacts of the financial and economic crisis on the automotive, chemical, pharmaceutical and food industries in the EU.

Külső szerző

IHS GLOBAL INSIGHT (Paris, France), Henrik MEINCKE (European Chemical Marketing and Strategy Association - ECMSA, The Hague, Holland), Benjamin BELOT and Anne-Charlotte PUPIN (ALCIMED, Paris Office) and Ben COOPER (Aroq Limited),

Strategies for the Improvement of Global Human Health

08-08-2006

This report is the final Deliverable of the project Global Human Health commissioned by the Scientific and Technology Options Assessment (STOA) of the European Parliament and carried out by the European Technology Assessment Group (ETAG). It contains the summary of the workshop Strategies For The Improvement Of Global Human Health held on 29 June 2006 at the European Parliament in Brussels. The issues and recommendations raised at the workshop suggest topics for future technology assessment projects ...

This report is the final Deliverable of the project Global Human Health commissioned by the Scientific and Technology Options Assessment (STOA) of the European Parliament and carried out by the European Technology Assessment Group (ETAG). It contains the summary of the workshop Strategies For The Improvement Of Global Human Health held on 29 June 2006 at the European Parliament in Brussels. The issues and recommendations raised at the workshop suggest topics for future technology assessment projects for STOA. Main issues raised were: - lack of successful coordination and cooperation in drug R&D; - lack of investment in research of neglected and rare diseases; - inequitable pricing of medicine; - lack of considering health systems issues in research and funding.

Külső szerző

ETAG (European Technology Assessment Group) ; Institute for Technology Assessment and Systems Analysis (ITAS), Karlsruhe ; Danish Board of Technology (DBT), Copenhagen ; Flemish Institute for Science and Technology Assessment (viWTA), Brussels ; Parliamentary Office of Science and Technology (POST), London, the UK ; Rathenau Institute, The Hague, The Netherland ; Elisabetta El-Karimy, Rathenau ; Robby Deboelpaep, viWTA

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Health threats from climate change: Scientific evidence for policy-making
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