BioWorld International Correspondent

LONDON - Attempts to harmonize the patchwork of laws covering human tissue-engineered products took a step forward last week with the publication of proposed rules to create a single European regulatory framework.

At the heart of the proposals drawn up by the European Commission is the establishment of a centralized marketing authorization procedure, to be overseen by an expert committee based within the European Medicines Agency (EMEA).

While there will be stringent requirements for risk management and traceability of all gene, cell or tissue-based therapies and all patients treated with them, EMEA will provide low-cost scientific advice to companies seeking registration. There will be special incentives for small companies also, including extended data exclusivity that will, in effect, increase the patent life of products.

The guiding philosophy proposed in the rules is that human tissue and cell-based products should be founded on voluntary and unpaid donation of material. There will be a set of general regulatory principles for controlling the entire class of products, overlaid by product-specific guidelines.

Gunter Verheugen, vice president of the European Commission said, "With this proposal, we guarantee the highest level of health protection for patients. At the same time we give the biotech industry a coherent EU-wide framework, which allows it to innovate, grow and create jobs." The proposals now go forward for consideration by the European Parliament and the European Council.

At present, human tissue engineered products largely fall outside the scope of current EU regulation. Different member states take different approaches, and the market is fragmented.

On a commercial level, tissue engineering is dominated by small biotech companies, of which there were 113 in 2003. Around 10,000 people are directly employed in the field. There are 35 mostly autologous products on the market, mainly for skin and cartilage replacement.

Across Europe the regulatory requirements vary from countries in which there is no specific regulation to others where human tissue engineered products are classified as medicinal products. Some countries do not have the appropriate expertise at the regulatory level, and in any case, manufacturers are forced to repeat the registration process for each country. Tellingly, there is not a single example of a human tissue engineered product that is registered in all EU member states.

The risk management and traceability rules will increase the cost of compliance for manufacturers, but the proposals reduce the risks and uncertainties of developing human tissue engineered products and should result in higher sales.

Although traceability of products to individual recipients is an extra layer of regulation compared to rules governing medicines, there is an existing system for tracing patients who receive certain blood products that could be adapted to this purpose.

Lincoln Tsang, chairman of the UK BioIndustry Associations Regulatory Affairs Advisory Committee and a partner at the law firm Arnold & Porter LLC, told BioWorld International, "In general the proposals are moving in the right direction in terms of helping companies in identifying what the standards are in advanced therapies. It's obviously helpful to small companies that rather than going to individual member states for approval, they go through a single process."

However, he pointed out that the proposals are unlikely to clear the field for the pan-European registration of products based on human embryonic stem cells because national governments can decide not to accept products on ethical grounds.

"This is a major problem [in creating a single market] because in some major states stem cell research is banned on moral grounds," he said.