The New EU Regulations – 21 Days and Counting!

The EU Directive will become Regulations…but when? September 26 the proposed regulations are scheduled to be released in draft form. Plans for implementation of the Interim Measures have already begun, but the regulations will not be finalized for 18-24 months while the politics takes over. My magic 8-ball tells me that there is a precedent on this side of the pond that can help us predict the future.

A few weeks ago I published a posting with a cheeky Brit–Lily Allen. Here’s one of Lily’s own favorites by a another talented British singer, song writer named Kate Nash.

Throughout the history of healthcare regulations worldwide there have been three rules that are never broken:

1. Regulations always get tougher.
2. Regulations are only partially effective.
3. Regulations cost everyone more money.

The PIP scandal lit a fire under the European Parliament, the Council and Notified Bodies. Now all three stakeholders are fighting to show the public that they are doing everything they can to ensure safety. Unfortunately, no matter what changes are made it is extremely difficult to prevent unethical behaviors.

Before I make predictions, we all need to remember that there is a larger news story–the European Economy.

The status of the European Economy will have the greatest impact on new regulations. My best evidence is the US FDA.

The FDA has been trying to improve the turnaround on submission reviews for my entire career. For a period of about 8 years, matching closely with the Presidential terms of George W. Bush, it seemed to get easier to get products through the FDA logjam. Then the global economy tanked and political winds changed in 2009.

Over the past three years, Republican’s have gained power and Congress is now pushing the FDA to actually improve the metrics for product approval. The FDA will now have 200 additional reviewers, and every plan for improving turnaround that has been tried is back on the table.  The FDA was given the funds to grow its army of inspectors first, and now the FDA is granted additional funds to hire additional reviewers and train them.

The European Union includes countries that are struggling to provide basic services, while other countries don’t want to bail their European neighbors out of debt. How is the European Parliament and the Council going to increase regulation of medical devices when everyone knows that regulations will cost more money?

The short answer is…they can’t.

One of two things must happen before true change can occur:

1. another healthcare scandal could trigger this change, or
2. the economy could improve.

Based upon the sluggish recovery of the US economy, I don’t see how #2 will happen in Europe during the next 18-24 months. I can’t predict #1, but historically scandals are years apart.

MAGIC 8-BALL TIME

I predict that the draft regulations will get watered down during the co-decision period. The most popular legislative tool is the “transition period”. For example, UDI legislation was passed in 2007 in the US but the proposed rule was not published by the FDA until 2012. The proposed rule includes a 7-year transition period for implementation of the new rule.

If the new EU regulation is finalized in 18-24 months, we can expect a long transition period during which various pieces of the regulations will be implemented. This transition period is essential for Notified Bodies to gradually increase their staff and for training new auditors. This will also give companies several years to organize their own plans for addressing the new regulations.

The one change I predict to happen quickly is consolidation. 60+ Notified Bodies are more expensive for the EU to support than a few large Notified Bodies. The FDA is a single, centralized regulatory body. The EU will not achieve the same degree of centralization, but I predict “a great consolidation”.

My final prediction is related to the vigilance process. In the US the MDR process has become highly automated and electronic submissions with a public database are the norm. This has allowed the FDA to rely on data analysis to identify problems and redirected the burden of data entry from the FDA to industry. We can expect Europe to follow this trend, by centralizing all vigilance reporting. The only remaining question about vigilance is how long will the transition period need to be for revision 8 (of MEDDEV 2.12/1).

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