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EU tissue and cell directive to be implemented in April
The European Commission adopts safety rules, paving the way for the new legislation.
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A European Union directive set to become binding starting April 7 should widely, but positively, impact Europe’s human allograft tissue industry.
Although it will significantly change the way European Union (EU) organizations and personnel already involved in tissue processing go about their business — and perhaps cause some existing tissue banks to close — the tissue and cells directive (2004/23/EC) is expected to herald in an era of generally safer tissues for human implantation.
Courtesy of David Armstrong |
The directive, adopted by the EU Council and Parliament in 2004, applies to allograft bone and soft tissues used in orthopaedic surgery, as well as human cells and related products, like bone marrow and stem cells. It does not apply to blood, blood components or organs.
Once implemented, the national competent authorities will be responsible for enforcing the directive in EU member states.
Those human tissue establishments currently meeting member states’ provisions, however, will have until April 7, 2007, to come into compliance with the directive, officials said.
New technical rules
In February, the European Commission (EC) adopted technical rules for the donation, procurement and testing of human cells and tissues throughout the European Union. The new rules will help with the implementation of EU legislation on quality and safety standards for tissues and cells, officials said.
Markos Kyprianou, EC commissioner for health and consumer protection, said: “Hundreds of thousands of EU citizens every year undergo some form of treatment based on the use of human tissues and cells, and they must be able to trust in the safety and quality of this process. The legislation that we have set down will ensure that this is the case — wherever the tissue and cells come from or are received within the EU.”
The new donation, procurement and testing directive requires donors to meet strict health criteria. It also helps ensure that those establishments involved in tissue and cell procurement, as well as in receiving such tissues and cells, meet a standard set of requirements.
“These rules will ensure a high level of public health protection in all member states and prevent the transmission of diseases via donated tissues and cells,” according to the release.
Protection needed
For patients in the European Union, this means that tissues they might receive during a procedure they undergo in a neighboring member state, rather than their own, would provide an equal amount of protection from transmissible diseases.
Officials expect to propose another directive later this year that will apply to tissue and cell storage, processing and preservation, according to information on the EC Web site.
This main directive and the newly adopted technical rules could not come at a more appropriate time in the evolution of worldwide tissue banking regulations. Hundreds of U.S. patients and some from Canada and possibly Europe are currently undergoing infectious disease testing after receiving human allograft tissue from Biomedical Tissue Services Ltd., a tissue recovery firm now being investigated by the U.S. Food and Drug Administration (FDA) and other government agencies.
Recovery agency problems
On Feb. 3, the FDA shut down the recovery agency and cited, in a press release, some of its procedural violations, including inadequate screening of tissue donors for risk factors for or clinical evidence of various communicable diseases.
Officials also found discrepancies between donor paperwork that Biomedical Tissue Services maintained and information contained in the donors’ official death records. This left possibly thousands of patients at risk for transmissible diseases because the donors of the tissue that they were implanted with did not undergo proper screening.
FDA officials said in a press release that although the actual risk of infection from those tissues was uncertain, it was likely low. To date, no cases of infection occurring related to the questionable tissue have been substantiated.
Last September and October, the FDA and the five tissue banks that acquired and processed the tissue in question recalled all affected allografts. For example, a Wright Medical Technology spokesperson told Orthopaedics Today in a phone interview last year that 25 of its GraftJacket units sold worldwide were among those allografts recalled. Seventeen of them were implanted in patients and were being tracked.
U.S. tissue rules
In recent years, the FDA published three rules governing human tissues and cells retrieved, distributed and used in the United States. The latest of these pertained to Good Tissue Practices (GTPs) and affected the manufacturing, processing and storage method used in conjunction with human cellular and tissue-based products, as well quality control programs.
Two other rules required human tissue establishments to be registered with the FDA and potential tissue donors to be screened for communicable diseases.
The EU directive is expected to introduce the kinds of safety standards that would hopefully keep such an incident from happening in Europe.
“It was enacted to ensure the safety of tissue — human tissue — coming into Europe, as well as ensure the safety of tissue processed in any of the EU states,” Helma Fernandez told Orthopaedics Today.
Fernandez is director of international marketing for the Musculoskeletal Tissue Foundation, Edison, U.S.A., a nonprofit tissue bank. She said the new directive would protect the safety of tissues and ensure they are legitimately and properly processed. However, the mandatory testing and processing required by the directive could negatively impact some of the smaller tissue banks now operating in the European Union, such as those located in hospitals.
“For instance, in France, where there used to be more than 60 small tissue banks … right now they will be required to comply with the EU tissue directive, which is very explicit regarding testing and … processing,” Fernandez said. Since some of those hospital “banks” are not currently set up to test or process human tissue, “many of them may be forced to close,” she said.
Cost of compliance is also a concern. For example, it would likely be too costly for occasional bank users to comply, Fernandez explained. Although this directive will further safeguard the procurement and processing of human tissues, “it will also make the import of any human-derived and highly processed tissues such as demineralized bone matrices very cumbersome and impractical due to local tissue bank involvement. This part of the directive may lead to many new technologies not reaching patients in various European countries,” she said.
The EU recognizes this problem and is working on another regulation on human tissue-engineered products, she said.