Whoosh! There goes another deadline

EFPIA Administrator January 23rd, 2013 No Comments

directive 2010/63“I love deadlines. I love the whooshing noise they make as they go by.”

                      – Douglas Adams


It had all been going so well. The path EU legislation must navigate is notoriously complex. Consultations, proposals, amendments – input from MEPs and compromises between national governments – the road is long and winding.

But for the EU’s directive on how animals are used in medical research, this lengthy process appeared to have produced a compromise which governments agreed would raise standards of animal welfare, reduce red tape by harmonising rules across Europe, and promote the 3Rs.

Scientists, some of whom initially worried that the new rules would make research more difficult, had their say during the consultation period and broadly accepted the final outcome. Yes, there will always be some who hope for less regulation – just as others will be disappointed that the law could not go further – but EU policy is a world of compromise and this directive looked to have struck a reasonable balance after a robust debate.

So you might have expected that the final step in the journey – turning the EU directive into national law – would be the least complex. Not so!

All 27 Member States should have had laws, regulations, and administrative provisions in place by November 2012 so that these could be in force by the beginning of this year.

At last count, most governments were behind schedule and struggling to meet the deadline. Perhaps this is because not all costs could have been anticipated at adoption of the directive and only now has everyone realised some additional bureaucratic and financial burdens that stem from the way countries interpret the provisions.

While local political and economic crises might be dominating the agenda in several Member States, the directive has been coming down the tracks for some time, so its transposition ought to be a fairly routine technical matter.


Never-ending story

The painstaking process of agreeing on a final EU text has been concluded; the debate is over – or at least it should be…

Let’s look at Italy as an example. Efforts to transpose the directive into Italian law have been complicated by amendments proposed by Italian politicians. Scientists in Italy have already raised concerns about this, warning that medical research in Italy could be jeopardised if the country fails to implement European law.

Italy, which has endured its share of controversies over animal research in recent months, could even be hit with fines for non-compliance with a law its government signed up to.

Are national parliaments set to re-fight the battles that were fought before the directive was agreed?

And, in light of our Shall It Stay or Shall it Go debate, is this the latest signal that animal research is no longer welcome in Europe? If so, what would this mean for European patients and for animal welfare standards?


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