The tensions over proposed changes to EU laws on medical devices encapsulate the challenges that face the European Union on a weekly basis as it tries to devise legislation that will be binding on member states while keeping all parties happy.
Patient safety
On the one hand, the new medical devices directive is responding to public concerns about patient safety in the wake of the PIP scandal which saw hundreds of thousands of women across the world sold defective products.
The EU operates a fragmented authorisation system that allows manufacturers to seek authorisation from any notified body – the scandal-hit French company PIP was authorised by a German body, for example.
The European Commission believes the system is lax and under-regulated – particularly in comparison to the US’s more stringent and centralised regime – and is pushing for common standards and regulations.
On the other side, industry representatives are staunchly opposed to the new rules, arguing that they are misguided, unworkable and unnecessary, and another example of the EU reacting impulsively to an isolated scandal to score populist points.
Today’s vote in the European Parliament in Strasbourg is only one stage in the laborious process that characterises EU decision-making.
The European Commission first published its proposals in 2011. Having studied these in detail and adding around 900 amendments, the European Parliament is now ready to vote on the legislation.
However, the Council of Ministers, representing the 28 member states, must also have a say, after which negotiations between the European Parliament and the council will then begin.
As with the many files that are winding their way through the European decision-making process, the pressure is on to secure final agreement on this dossier before the European Parliament breaks up next summer and a new European Commission is elected. While it may be in the interest of industry players to delay agreement on legislation, uncertainty hanging over the industry in the event that the legislation is not finalised may be just as damaging.
Whatever the outcome, the final agreement it likely to be significantly different from the original proposal published by the European commission in 2011, as is the case with virtually all EU legislation. Whether this is testimony to the EU’s healthy spirit of compromise, or the abiding influence of lobby groups, is another question.
Either way, this is one EU directive that the medical device industry in Ireland is going to keep within its sights over the next few months.
