Nicola While: Time is running out for EU health legislation

The end of 2012 is the unofficial deadline for all legislative proposals to be published if EU decision makers stand any chance of finalising debate on the issue before the end of the current parliamentary term in mid 2014.

This arbitrary cut off date means that any dossiers not published or not progressing rapidly by the end of the year are likely to fall foul of the run up to the June 2014 European Parliament elections when MEPs minds will be concentrating on thoughts of re-election rather than on policy making.

Under EU rules, any legislative proposal that is not completed by the end of the parliamentary term can be scrapped by the newly elected cohort of MEPs and debate restarted from zero.

Four important dossiers for the UK health sector have been published this year and debate is well underway. The revision of the rules on the mutual recognition of professional qualifications is in its first reading stage. MEPs are due to take their first vote at the end of the year. National governments are also progressing well in their discussions on this and the European Commission is hopeful that agreement will be reached in 2013.

The revision of the data protection rules was published at the start of 2012. This massive dossier will cover all aspects of data protection from social media to medical records and the commission wants the proposals to have worldwide jurisdiction. As such they have run into opposition from international corporations and governments across the globe. Reaching a final agreement on this dossier before mid-2014 may prove tricky.

Publication of the proposals on the revision of the Clinical Trials Directive and the revision of the Medical Devices Directive met the end of 2012 target and have just began their legislative passage. These are unlikely to run into major delays due to their relatively uncontroversial nature and as such should meet the 2014 deadline.

However there are some probable casualties of the election cut off point. Following the recent shock resignation of the European Commissioner for Health in light of allegations of undue influence, the long delayed revision of the Tobacco Products Directive which had been expected to meet the 2012 deadline now looks likely to be moved back to summer 2013, thus all but guaranteeing that agreement will not be reached by mid 2014. A victory, some are saying, for the tobacco industry who have been pushing hard to dilute any future proposals in this area.

The recent extension of the deadline for the EU social partner process on the European Working Time Directive from autumn 2012 to 31 December 2012 may also impact on future work in this area. If the social partners fail to reach agreement, the European Commission had been planning to come forward with new legislative proposals. However in light of the changed timetable, any Commission proposal would not see the light of day until spring 2013 at the earliest. Bearing in mind that the last legislative round of negotiations on the EWTD failed to reach an agreement after five years of debate, it is safe to say that the 2014 elections will be long gone before agreement on any Commission proposal in this area is reached.

Nicola While is the BMA’s EU policy manager and is based in Brussels.