Medical Device Daily Contributing Writer

and Staff Reports

Just days after the presidential veto on further funding for embryonic stem cell research in the U.S., researchers have avoided the same fate in Europe – but only by a hairsbreadth. European Union science ministers agreed by a slender margin on July 21 to continue funding such research beginning in 2007, subject to tight national controls.

Emboldened by the U.S. example, Germany mounted a vigorous last-minute campaign to derail EU plans for a seven-year research funding program, now in the final stages of negotiation, on the grounds that it offered “financial incentives to kill embryos.”

At a specially convened meeting of the EU Council in Brussels, Belgium, German Science Minister Annette Schavan insisted: “We must achieve an appropriate balance of interests, and conserve broad support for human life from its conception.” She said the current plans do not impose sufficient standards, and she proposed the incorporation in the EU research program of an explicit ban on funding of embryo research.

The German campaign, which had gathered pace since President George Bush's veto announcement of July 19, won support from Austria (“This destruction of human embryos is not something we can support”), Poland, Italy, Luxembourg, Malta, Lithuania and Slovakia.

But in a long and unusually lively council meeting, a majority of member states indicated their support for the research program and its backing for embryonic stem cell research.

The Swedish minister described stem cells as “one of the most important possibilities we have for overcoming painful and disabling diseases.” The Portuguese minister said: “One country's sensitivities must never be allowed to stand in the way of collaboration among other member states.”

One by one, support for the research program was declared by Hungary, Belgium, the Czech Republic, Greece, Spain (“Embryo stem cell research is an important scientific adventure, for Spain and the whole of Europe”), the UK (“It would be ethically unacceptable to withhold these advantages from patients”), Cyprus, Denmark, the Netherlands, France (“We cannot replace embryonic stem cell work with adult stem cell work”), Estonia, Latvia and Ireland.

Crucially, Slovenia, which had indicated concerns over the plan in the week before the council meeting, withdrew its reservation and gave its approval, thus denying the opponents of embryonic stem cell research the necessary votes to constitute a blocking minority under EU voting rules.

The result was a victory for a compromise formulation, under which EU funding can be made available for embryonic stem cell research in countries where national law allows it, and subject to a raft of ethical and regulatory controls. The compromise will now go back to the European Parliament in the autumn for final approval, which should allow the new multi-billion dollar funding program to start from the beginning of 2007.

EuropaBio, the European association for bioindustries, welcomed the agreement. “Continuing the funding on embryonic stem cells research at the European level is a positive signal for European biotech research, which may one day offer hope for patients suffering from diseases like Parkinson's and Alzheimer's,” said its secretary general, Johan Vanhemelrijck.

Companies consider skin replacement merger

Celltran (Sheffield, UK) and Innogenetics (Ghent, Belgium) said they are in talks about combining their skin replacement cell therapy businesses, but they did not give any information on the nature of the deal, saying the details are yet to be finalized.

“We are expecting to conclude this during the third quarter of this year, but the structure is not finalized as yet,” David Haddow, operations director of Celltran, told Medical Device Daily's sister publication, BioWorld International.

The planned deal would bring together privately held Celltran with Innogenetics' wound care arm, XCELLentis. While Celltran's autologous skin replacement therapy, myskin, is marketed in the UK, XCELLentis has an allogenic product, Lyphoderm, which consists of freeze-dried cultured skin cells, in Phase II development.

Haddow said the technologies and products of the two companies are complementary. “The mix of autologous and allogenic therapies gives a very good combined fit,” he said. While myskin is manufactured to order at the company's GMP facility in Sheffield, XCELLentis' Lyphoderm is available off the shelf.

Haddow said both products are “very effective” clinically and the choice of which one to use would depend on the needs of each patient and the opinions of their doctors.

Celltran was spun out of Sheffield University in 2000, and has since raised £ 4 million ($7.4 million). The largest shareholder with 26.8% is BioFusion, a technology management company that has exclusive rights to commercialize life sciences research carried out at Sheffield University. Celltran's key intellectual property is not in its cell culture methods, but in the surface that is used to deliver the cells.

To date, the product has been used mainly in the treatment of chronic wounds and burns, but Haddow said there are other potential applications and Celltran is in talks with potential licensees.

XCELLentis was spun out by Innogenetics in February 2001 as a wholly owned subsidiary.

Docs express concerns about EMRs

In a recent issue of the British Medical Journal (BMJ) several physicians expressed strong views on whether patients should have to opt in or out of electronic patient records (EMRs).

Many in the medical profession are concerned that, in the proposed summary care record, data will be accessed with no further input from the patient, and this is not being made sufficiently clear to the public, Drs. Paul Cundy and Alan Hassey said in a letter to the BMJ. “Patients and clinicians must have confidence that information will be secure and shared only with patient consent,” they said.

Another letter in the same issue argued that the EMR is incompatible with the doctor-patient relationship, and is a direct and serious threat to patient confidentiality. Its author, Michael Foley, suggests that the huge sums of money being invested in its development might be more usefully spent on improving patient care than on compromising their privacy.

If patients' health records are made universally available, confidentiality is put at risk and the potential consequences are serious, added Anthony Winston, consultant in eating disorders, in a final letter. “When serious harm can result from a course of action, explicit consent is required. The Royal College of General Practitioners is right to insist on opting in,” he wrote.