Medical Device Daily Contributing Writer And MDDs

BRUSSELS – Disagreements over the ethics of advanced therapies have derailed talks on new European Union rules aimed at improving patients’ safe access to gene therapy, somatic cell therapy, and tissue engineered products. The European Parliament was scheduled to debate the proposals in October, but sharp conflicts of view in the parliament’s health committee have led to a postponement until early 2007.

The new rules, proposed by EU officials in 2005, would create a harmonized system for obtaining EU-wide market access for new products. But skeptical politicians tabled numerous objections in advance of the scheduled debate, claiming that the draft legislation ignored vital ethical issues.

In the resulting confusion, the draft opinion the health committee was intending to adopt was withdrawn, and the parliamentarian responsible for drafting the committee’s opinion is unlikely to present a revised text until 2007.

The delay means that the vacuum in the regulatory framework — with no “one-stop-shop” for European authorization — will persist. At present, the biotech industry says it faces real difficulties in putting new advanced therapy products on all member state markets at the same time, because of the financial and administrative burden of meeting 25 different legal requirements.

Thebiotech industry associationEuropaBio (Brussels) wants the new rules to focus on patient safety and on the needs of industry and the regulatory authorities. Ethical questions, it says, should be dealt with at national level.

Ethics are not a subject that this law can — or should — regulate at European level, in the industry’s view. It points to the divergence of national views revealed by recent debates on subjects such as embryonic stem cell research. And the situation will become more complex since the EU’s membership will rise from 25 member states to 27 at the beginning of 2007, when Bulgaria and Romania will join.

“Unnecessary repetition of recently concluded ethical debates that are reflected in existing EU legislation should not be allowed to delay this urgently needed product regulation,” EuropaBio said. “Member states should decide for themselves which products will be allowed and which not.”

The industry also wants loopholes to be closed that could allow hospitals an easier route than companies in obtaining market authorization for advanced therapies. “No matter who prepares the treatment — companies or hospitals — it should adhere to the highest standards of safety and efficacy,” EuropaBio said.

Siemens gets ‘go’ to buy Bayer diagnostics

Siemens (Munich) said it has received the green light from the European Commission to acquire Bayer’s (Leverkusen, German) diagnostics division (Tarrytown, New York) without restrictions. The approval was granted today by the European Commission, following the earlier approval by U.S. antitrust authorities at the beginning of October.

This follows the acquisition of the U.S. firm Diagnostic Products Corporation (DPC; Los Angeles), completed at the end of July (Medical Device Daily, July 31, 2006). Upon completion of the Bayer acquisition, expected by early 2007, both companies will be merged and will operate as Siemens Medical Solutions Diagnostics , a U.S.-based subsidiary and part of Siemens Medical Solutions .

“This has paved the way for Siemens to create the world’s first full service diagnostics company,” said Professor Dr. Erich Reinhardt, member of the managing board of Siemens and president/CEO of Siemens Medical Solutions, following the Commission’s decision.

He said that the company’s entry into the in vitro diagnostics market will enable the company to combine the entire imaging diagnostics, laboratory diagnostics and clinical information technology value chain under one roof and offer its customers customized solutions.

“This will further improve the quality and efficiency of healthcare,” he said.

DataTrak chosen as eClinical provider

Datatrak International (Cleveland), a company focused on global solutions for the clinical trials industry, reported that TheMedical Research Network (Milton Keynes, England) — part of the Healthcare at Home (Staffordshire, UK) group of companies that offers a portfolio of clinical trials services including the ability to administer therapies in the home — has selected Datatrak’s eClinical suite as their preferred enterprise information platform for their clinical trial offerings.

The core business of The Medical Research Network is the provision of clinical trial-based services to patients within their home or “domiciled environment.” Through its affiliation with Healthcare at Home, the UK’s largest homecare provider, Medical Research Network nurses deliver and administer trial medications or device therapies directly to the patient.

The Medical Research Network’s clients include the National Health Service , managed care and private insurance carriers and pharmaceutical and biotech companies both inside and outside of the UK. The emphasis is on direct access to patients and investigative sites for improved delivery of care and clinical research.

Medical Research Network personnel will utilize Datatrak eClinical as their platform for clinical trial data collection through wireless Internet access to Datatrak’s global application service provider (ASP) offering. eClinical features an intuitive user interface and the capability of offering the integrate eClinical platform.

Datatrak delivers a portfolio of software products created to accelerate clinical research data from investigative sites to clinical trial sponsors and ultimately the FDA, faster and more efficiently than manual methods or loosely integrated technologies. The company has offices in Cleveland, Ohio, Bonn, Germany, and Bryan, Texas.

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