European Tissue-Product Rules Nearing Completion

Originally Published MDDI May 2005

NEWSTRENDS

Erik Swain

European regulators are not usually known for taking industry input into account. But that will not be the case in 2005 as the European Union moves to issue rules on human tissue products, according to a consultant. So device companies who want to sell tissue products in Europe should pay close attention to two processes occurring this year.

“This could be tricky, because in Europe there are really only two kinds of regulatory framework for healthcare: one for pharmaceuticals and one for devices,” said Phil Brown, senior consultant in Quintiles Consulting's Bracknell, United Kingdom office. “For borderline products such as tissue products, you'll need to know when each applies.” He spoke in March at an audio conference that was sponsored by ForeignExchange Translations Inc. (Boston).

First up is a guidance that will play a large role in implementing the European Commission's Procurement Directive. Directorate General SANCO, which is in charge of general product safety, is writing it. What tissue-product manufacturers need to understand are the sections on donation, procurement, and testing of human tissues, Brown said. This covers, among other things:

• Designation, authorizing, and licensing of tissue establishments.
• Selection criteria of donors.
• Screening tests of donors.
• Procurement, receipt, and distribution procedures.

The second rule-making process covers manufacturing and marketing authorization. Directorate General Enterprise, which is responsible for issues concerning the free movement of goods, has jurisdiction.

Among the issues covered will be approval processes for autologous and allogenic tissue products, the exact role of the European Medicines Agency, and whether there will be any incentives for small manufacturers, Brown said.

“You will need marketing authority for both the tissue establishment and the product,” he said. “It should be similar to what you go through for a Class III medical device. What could be favorable is that this should be a regulation and not a directive. That means the document itself will be transposed directly into the laws of member nations, which means there will be no national variances.”

As far as selling tissue products in Europe, Brown said, there is a loophole that could allow firms to gain access to countries that have more-restrictive regulations without having to navigate those tougher rules. Once a product is approved for sale in any European Union nation and has been shipped there, it can be shipped from there to any other European Union nation with virtually no restrictions. That means a firm could get approval to sell a product in a less-restrictive nation, ship all the product to that country, and then send it to the more-restrictive EU member states from there, he said. However, Italy is considering legislation that could close that loophole, and other nations could follow suit, Brown said.

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