BioWorld International Correspondent
BRUSSELS, Belgium - The European Union last week agreed on new safety rules for handling human cells and tissues, as the European Parliament on Dec. 16 voted for a text that also has won the support of EU ministers and officials.
Member states will have two years to transpose the EU rules into national law.
The new rules focus on the quality and safety aspects of cells and tissues donated for human applications. They do not cover cells and tissues used in research. And instead of imposing limits on stem cell research - as many of the conservative elements in the Parliament had been seeking - each EU member state will be entitled to make its own decision on which specific cell types are covered. The text merely refers to a general duty imposed to protect public health, reinforced by a reference to the specific health risks that could arise from the use of embryonic stem cells. And public and private sector tissue banks are to be allowed to operate alongside each other under the same set of rules.
The second-largest political group in the European Parliament, the Party of European Socialists, called the outcome a "victory for common sense."
"Thankfully," said spokesman David Bowe, the new regime "will enable a proper medical trade in human tissues and cells across Europe, and ensure the continuation of research into tissue-based treatments and therapies."
After the fears of strict limits on cell research, the European biotechnology industry welcomed the vote, which it described as helping to ensure safety and quality of human tissue and cells. "It is a good first step in building a set of rules for human cell and tissues," said Hugo Schepens, secretary general of EuropaBio, the European association of bioindustries.
Schepens was critical of one aspect of the new rules: in a late change to the text, the legislation will now cover the processing, storage and distribution of final manufactured products.
"We are disappointed that innovative products derived from human cells and tissues, like some of the new heart treatments coming on stream, will be covered by this directive," he said.
However, the decision is likely to be only an interim measure. The EU already is preparing new rules on tissue-engineered products to fill in the gap between current EU rules covering medicines and devices. Further rules are likely to come into effect around the same time as the cells and tissues rules and should take over the regulation of tissue-engineered products.