Menu Close

EU struggles with rules on therapeutic tissues and cells

Struggles within the European Union (EU) are jeopardizing a longawaited directive on the safety of donated human tissues and cells. The Council of Health Ministers wants companies to abide by the new rules, which according to industry would stifle innovation. The European Parliament (EP), on the other hand, demands inclusion of a ban on human cloning. Yet if all cannot agree by mid-December, the whole directive could end up being shelved.

For years, biotech companies have been begging the European Union to regulate the use of donated human tissues and cells for medical treatments. Because while the sector is seen as very promising, wider use of donated tissues will also create more health risks comparable to the HIV contamination of blood products in the 1980s. Clear and homogeneous rules are needed, companies feel, since public trust could evaporate quickly if an accident happened with no framework in place. “This has been one of the few times industry has asked for more government regulation,” says Heidi de Wit, associate director for corporate affairs at Genzyme Europe (Brussels, Belgium).

The draft Directive on Quality and Safety Standards for Human Tissues and Cells (2002/0128), first drawn up by the European Commission (EC: Brussels, Belgium), was intended to fill part of the gap.

Currently, the only EU rules on treatments based on human cells are laid down in a directive that governs market approval of medicinal products (2003/63). Its recently added section ‘somatic cell therapy’, however, is incomplete and unclear, causing member states to deal differently with innovative therapies.

The confusion turns getting new products to the European market into “a nightmare,” says Shayesteh Fürst-Ladani, manager of global regulatory affairs at Baxter Bioscience (Vienna, Austria). Her own company has had trouble getting its fibrin sealant, consisting of cultured skin cells spread out on a matrix for application to wounds, approved throughout Europe, and faces more hurdles with products still in its pipeline. Bumping into similar barriers is Genzyme, a global biotech working on things like cartilage replacement and injection of genetically modified stem cells to strengthen weakened hearts (See picture).

And it’s not just headaches from a patchwork of regulations that could keep treatments from reaching the market, says Genzyme Europe’s senior vice-president Erik Tambuyzer. The current absence of a European stamp of approval, he fears, discourages from reimbursing such treatments, preventing a new market sector from taking root.

Partly in response to industry’s wishes, the EC Directorate General for Health and Consumer Protection (in French speaking Brussels known as Sanco) in 2002 drafted minimum quality and safety standards for human tissues and cells. To protect both tissue donors and receivers, Sanco basically proposed that only “accredited tissue banks” should be allowed to obtain and screen donated tissues and cells, narrowly guided by its provisions.

The debate got heated up when the European Parliament, in its first reading in March 2003, demanded a host of ethical provisions, including a ban on the use of cloned human embryos and a prohibition on payments for human body parts. ‘Safety and ethics cannot be separated,’ says Peter Liese, Parliament’s rapporteur on the matter, responding to critics who say EU treaties do not allow for safety rules to be used as a way of imposing ethical boundaries on member states. (Currently several countries, including the UK and Sweden, would allow future use of cloned human embryos to treat disease.)

The Council of Health Ministers, while therefore strongly rejecting Parliament’s ethical additions, in May 2003 added some ideas of its own. Instead of just regulating the handling of source materials and transplants, it wanted Sanco to also cover industrial manufacturing and distribution of derived products, as long as no good market regulation for such products is in place—a situation that could easily last several years.

The biotech industry wants no add-ons at all.

Using consumer and public health rules to regulate industrial products, as proposed by the Council, would create problems, says Fürst-Ladani, because many companies would have a hard time getting accredited as official ‘tissue establishments’, thus forcing them to have publicly funded tissue banks manufacture and market their products. Moreover, says Tambuyzer, the Sanco directive lacks essential market provisions, such as assessment of product safety and efficacy, protection of intellectual property and sensitive clinical data, and a clear definition of a company’s liability in case something goes wrong.

A Europe wide ban on therapeutic human cloning, furthermore, would hardly qualify as a rule `sufficiently broad as to allow scientific and medical research to accommodate the developments (..) over the next few years,’ as asked for by an October 2003 position paper published by the European bioindustry association (EuropaBio, Brussels) called ‘Human stem cell research: a novel technology that will benefit patients’.

In the end, because of EU decision making procedures, all three legislative bodies will have to agree on a compromise or else there will be no directive at all. With a second and final Parliament vote scheduled for December 15, last minute negotiations between Parliament, EC and Council are now in full swing. On November 4, the EP’s Environment Committee (ENVI) kicked off the end game by vowing to stick to its key ethics provisions. “We can move on some points,” rapporteur Liese said after the vote made on that day, “but the Commission [and the Council will have to move, too.”

With closed-door deliberations ongoing and key provisions still up in the air, biotech lobbyists are left wondering what to hope for: having unfavorable EU regulation or having no regulation at all. Yet some still dare hope for a happy ending, getting all industry wanted. “I think all parties will find a common position, ” says Fürst-Ladani. “If not, it will be politically disadvantageous for all of them.”

Related Posts