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MEPs support use of common training framework for pharmacy and veterinary medicine specialty recognition

The Internal Market Committee (IMCO) of the European Parliament has voted to allow Common Training Frameworks to be used for cross-border recognition of pharmacy and veterinary medicine specialty qualifications.

At its meeting on 23 January 2013, IMCO Members of the European Parliament (MEPs) agreed a series of compromise amendments to lift restrictions that would prevent post-graduate specialties of automatically recognised professions from forming a common training framework.

A common training framework is a proposal from the European Commission that would allow nine countries or more to form a voluntary arrangement similar in effect to mutual automatic recognition for a qualification. Benefits of the proposal include the fact that not every country in the European Union would need to participate, and that the recognition can be based on an agreed competence framework rather than upon requirements for strict agreement on the duration period of a qualification.

However, under the Commission’s proposals of December 2011, there was an explicit restriction that the frameworks could not be used by any of the seven automatically recognised professions (such as pharmacy and veterinary medicine), including for the purposes of specialty recognition.

The new IMCO amendments lift these restrictions whilst also addressing the Commission’s concerns, by making clear existing recognised professions and specialties must not be affected by any new framework.

EAHP President Dr Roberto Frontini welcomed the Committee vote and said:

“I am delighted that MEPs of all political parties have seen the inherent sense in opening up the Common Training Framework to be used for the cross-border recognition of pharmacy specialties.

The whole purpose of the Directive on the Mutual Recognition of Professional Qualifications is to improve the labour mobility of professionals for the benefit of citizens, the European economy, and the operation of high quality health services that put patient safety first.

So when a very practical proposal comes along to assist qualification recognition, it is logical that it should also apply for unrecognised specialties of the automatically recognised professions.”

EBVS President Dr Peter O’Brien said:

“Whilst common sense has appeared to prevail in the European Parliament there is still more to do in persuading others, including national governments, before the process of reforming this Directive is complete.

EBVS and EAHP will continue to work with our partners in other professions, such as the European Union of Medical Specialists (UEMS), to ensure we achieve the best possible outcomes for specialty mobility in Europe.”

More information here. 

Draft Report by European Parliament on Clinical Trial regulation published 

The European Parliament’s Health Committee (ENVI) has published a draft report of its views on proposed reforms to clinical trial regulations across Europe. 

The report is an initial response to the European Commission’s July 2012 proposals for reforming the existing regulatory framework for clinical trial initiation, approval, conduct and submission, which recommend the replacement of the existing Directive with a more harmonised Regulation. The new Regulation would create a single submission procedure and central European information portal. The information portal is proposed to give more public transparency in relation to the results of submitted trials. The regulation would also permit a more risk-based approach to trial regulation with, for example, less stringent regulatory requirements related to trials for extending the indications of medicines already in use. The proposed regulation would also allow for multi-sponsorship of trials.

The UK MEP Glenis Wilmott (Labour, East Midlands), the lead rapporteur for the European Parliament on the subject file, published her draft report on 31 January 2013.

Ms Wilmott’s report includes proposed amendments that:

• seek greater clarity on the requirement for prior approval for a clinical trial by an ethics committee, in accordance with the Helsinki Declaration;
• express a desire for greater harmonisation of ethics committees processes in different countires through the sharing of best practices, a process which the Commission should facilitate;
• enable more stratified analysis of clinical trial results by age and gender;
• require the Commission to develop good practice guidelines with regard to patient involvement in ethics committees;
• make necessary the communication of reasons for withdrawal of a clinical trial
• encourage provision of information to patients on the results of clinical trials they have been involved in;
• require “lay summaries” of clinical trial results to be produced, to enable wider understanding; and
• mandate longer periods of trial result archiving.

Colleagues of Ms Wilmott on the Parliament’s ENVI Committee are invited to table further amendments until 26 February 2013.

EAHP is collaborating with other health professional, research and public health organisations to ensure the proposed regulation will meet the needs of trial result transparency and patient participation, in accordance with the EAHP policy statement of June 2012. 

More information here.