Disagreements over the ethics of advanced medical therapies, such as gene therapy, somatic cell therapy and tissue-engineered products, appear to be stalling talks on new European Union rules aimed at improving patients' safe access to these new medical opportunities. 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.
Proposed by EU officials in 2005, the new rules would create a harmonized system for obtaining EU-wide market access for new products. But politicians expressing skepticism 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In the resulting confusion, the draft opinion the health committee was intending to adopt was withdrawn, and the parliamentarian responsible for drafting the committee's opinion is unlikely to present a revised text until 2007.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.
EuropaBio (Brussels), Europe's biotech industry association, 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 the national level.
Ethics are not, according to the industry, a subject this law can — or should — regulate at the European level, pointing, for instance, to the divergence of national views on subjects such as embryonic stem cell research. The situation is bound to 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."
Targets: fraud, corruption, counterfeiting
Europe is currently addressing a variety of damaging practices in its healthcare. One effort is targeting healthcare fraud and "corruption" in general, another is targeting the issue of counterfeiting.
Over the past month, the European Healthcare Fraud and Corruption Network (EFHCN; Brussels) has been addressing the issues of fraud and corruption, saying that an estimated £30 billion-£100 billion are lost every year to healthcare crimes. Starting Nov. 9 and continuing through Dec. 9 — the latter date United Nations Worldwide Anti-Corruption Day — members of the EFHCN are promoting fraud awareness messages in 14 countries to roughly 210 million people.
Dermid McCausland, president of EFHCN, said, "[O]ur members [have been] pushing hard-hitting messages on the effects of fraud and corruption. The citizens of Europe need to know this plague on our healthcare systems threatens our lives and those of our families. Whether it is an opportunist thief or the organized criminal gang, money lost to fraud and corruption means less money spent on life-saving operations and medical equipment."
Stuart Gilman, head of the Anti-Corruption Unit and the Global Programme against Corruption (UNODC), said, "Public health services can be so degraded by corruption that bribery or gifts become the norm for receiving any medical treatment. Corruption turns healthcare on its head, so that the average citizen views a clinic or hospital as likely to cause harm as to make them better."
In another effort, the World Health Organization (WHO; Geneva) and its partners have rolled out what they call "the first-ever" International Medical Products Anti-counterfeiting Taskforce (IMPACT). IMPACT held its first meeting in Bonn, Germany, in October, launching pilot programs in three countries as a tool to strengthen countries' legislative capacity to deal with medical counterfeiting.
WHO said that IMPACT will develop five actions embracing the different national and international sectors related to counterfeiting: legislative and regulatory infrastructure; regulatory implementation; enforcement; technology; and risk communication.
WHO says counterfeit products, both devices and medicines, "are increasing as counterfeiters' methods become more sophisticated, infiltrating official channels of distribution as well as using illegal web sites to sell their wares." It said the concerns are greatest in countries with weak regulatory controls. "These are often the countries with the highest burden of disease, the poorest populations and the greatest need for reliable medicines."
The taskforce is made up of WHO Member States and more than 20 other major stakeholders, including Interpol, the World Customs Associations, patients' and medical organizations, the World Bank and the International Federation of Pharmaceutical Manufacturers & Associations.
Encore acquires Cefar
Encore Medical (Austin, Texas) has aquired Cefar (Malmo, Sweden), a European provider of electrotherapy and rehabilitation devices. Encore said it plans to merge Cefar into Compex (Lausanne, Switzerland), its European electrotherapy subsidiary, to create what it said would be "the largest electrotherapy company in the world outside of the U.S." The combined company will be led by Bjorn Lenander, CEO of Cefar.
Terms of the acquisition were not disclosed.
Encore makes rehabilitation and orthopedic implant products and said its strategy for the merged company is to develop both the professional/medical and consumer markets for electro stimulation across Europe and internationally, continuing to trade under both the Cefar and Compex brands.
Human cell, tissue rules tightened
The European Union has imposed additional quality and safety standards for human tissues and cells, covering processing, preservation, storage and distribution. The move follows the adoption last February of new safety rules for donation, procurement and testing.
The new rules set out accreditation procedures for tissue banks and processes for tissue and cell preparation — including notification of serious adverse reactions and events to national authorities, and annual reporting to the European Union.
A tissue establishment must have an approved organizational structure and operation procedures, and must apply a documented quality management system. The rules detail the requirements for staff, equipment and materials used, for documentation and record keeping, and for reviewing quality through audits.
To ensure traceability of human tissues and cells from the donor to the end user, the rules define the basis for a single European identifying code for all donated material. In Europe, these tissues or cells are frequently acquired through cross-border exchange, and EU citizens also receive treatment in other EU countries.
The EU first proposed binding requirements for the safety and quality of human tissues and cells from patient to donor in 2002. That has now resulted in new legislation, and these new technical standards which will go into effect at the national level by November 2007 (with a delay until June 2008 for the coding requirements).
Further guidelines concerning the single European identifying code for human tissues and cells are expected to be released early next year.
Chan targets people of Africa, women
Dr. Margaret Chan of China has been named the next director-general of the World Health Organization (WHO; Geneva). Chan told the World Health Assembly she wanted to be judged by the impact of WHO's work on the people of Africa and on women across the globe. "What matters most to me is people, and two specific groups of people in particular. I want us to be judged by the impact we have on the health of the people of Africa and the health of women," Chan said in her acceptance speech. She said that these will be two "key indicators of the performance of WHO."
"All regions, all countries, all people are equally important. This is a health organization for the whole world. But we must focus our attention on the people in greatest need," she added.
Chan was nominated as director-general by the WHO executive board and her appointment was confirmed by the World Health Assembly. The director-general is WHO's chief technical and administrative officer. She was previously WHO assistant director-general for communicable diseases and representative of the director-general for pandemic influenza.
The procedures for the nomination and election process were decided following the sudden death May 22 of WHO Director-General Dr. Lee Jong-wook, and the WHO executive board then decided on an "accelerated process" for electing a new director-general.
Gambro to refocus, reorganize
With its $3 billion divestment of its dialysis clinics in the U.S. to DaVita (Torrance, California) last year, Gambro (Stockholm) became a smaller, more focused company. And last month it unveiled a plan to continue its focusing process, saying that it will restructure to create three independent companies.
The plan calls for its Renal Products division (Denver, Colorado), a developer of products for renal therapy, to become the new Gambro. Gambro Healthcare (Stockholm), an operator of renal clinics, and Gambro BCT (Lakewood, Colorado), specializing in blood processing, will gradually become independent companies with their own boards and independent governance. When the reorganization is completed, they will operate under a holding company, Indap.
During a transition period, until Gambro BCT and Gambro Healthcare are legally reorganized, Gambro AB will handle governance issues for all three entities.
RaySearch, Philips in radiation R&D pact
RaySearch Laboratories (Stockholm, Sweden) reported a long-term license and development agreement with Royal Philips Electronics (Amsterdam, the Netherlands) covering a suite of new products within the adaptive radiation therapy sector. The agreement covers three products, the first of which will be launched during the second half of 2007.
RaySearch said adaptive radiation therapy is considered to be the next technology shift within radiation to increase precision by taking into account changes in the patient's anatomy during treatment, thus making it possible to deliver higher doses to the tumor and reduce side effects.
Intensity modulated radiation therapy (IMRT) improves treatment quality, but to achieve an even better result, software is required to deal with problems that arise due to changes in the patient geometry over time. By taking, for example, X-rays during the course of treatment, and feeding back the information, the treatment can be corrected so that errors can be avoided or dealt with, RaySearch said, calling this approach adaptive radiation therapy.
With the agreement, three products within adaptive radiation therapy will be developed, it said: a tool for IMRT using strictly geometrical information about the patient's anatomy; a product facilitating more advanced adaptation of the treatment and taking into account dosimetric aspects; and a product for delivering "full four-dimensional adaptive radiation therapy."
RaySearch and Philips said they already are involved in research activities within adaptive radiation therapy, including cooperation with Princess Margaret Hospital (Toronto), which began in 2000.
RaySearch was spun off from Karolinska Institute (Stockholm) in 2000.
Abiomed adds to Japan agreement
Abiomed (Danvers, Massachusetts) reported signing a five-year distribution agreement with Medix Japan (Tokyo), a distributor of cardiac assist devices.
Building on an eight-year relationship with Abiomed, Medix also said it intends to initiate clinical trials in Japan during Abiomed's FY08.
The agreement provides for distribution of Abiomed's AB5000 and Impella products and includes a minimum purchase of Impella products of $11 million within the first 18 months following regulatory approvals in Japan. The balance of the purchase commitment is for Abiomed's other products and begins in Abiomed's 1Q08.
"Interventional cardiologists and cardiovascular surgeons in Japan can now look forward to incorporating the Impella and AB5000 product platforms into their treatment of patients in acute heart failure," said Yasu Matsuoka, president of Medix. "Our regulatory and specific cardiovascular expertise and distribution partners make our partnership with Abiomed an ideal fit."
He added, "We believe that this technology will have a profound effect on patient care and are totally committed to working with our government officials and the Abiomed team to bring these products to the Japanese market as rapidly as possible."
Michael Minogue, president/CEO of Abiomed, said Japan represents a sizeable market for his company's recovery technologies. "Heart recovery is one of the main priorities in Japan, and their physicians often provide some of the most elaborate evidence-based scientific publications in the world."
Abiomed manufactures the AB5000 Circulatory Support System and the BVS 5000 Biventricular Support System for the temporary support of all patients with failing but potentially recoverable hearts. It offers the minimally invasive Impella Circulatory Support System in Europe.
EPIX wins Canadian approval of Vasovist
EPIX Pharmaceuticals (Lexington, Massachusetts) reported that Health Canada's Health Products and Food Branch has approved its blood pool imaging agent Vasovist (gadofosveset trisodium injection) for marketing.
Vasovist is indicated for contrast-enhanced magnetic resonance angiography (MRA) to visual abdominal or limb vessels in patients with suspected or known vascular disease.
Vasovist is an injectable intravascular contrast agent designed to provide imaging of the vascular system through MRA which has been developed in collaboration with and will be marketed by Schering (Berlin). Target indication for Vasovist is MRA imaging of non-coronary vascular disease.
In October 2005, the European Medicines Agency granted approval of Vasovist to Schering for all 25-member states of the European Union. It also has been approved in Norway, Iceland, Switzerland, Australia and Canada.
Andrew Uprichard, MD, president of Epix, said the approval represents the 30th country for Vasovist marketing.
"We remain in dialogue with the [FDA] regarding the path to approval for Vasovist in the U.S.," Uprichard said. "In addition to this milestone for Vasovist, data from our Phase IIa clinical trial of EP-2104R, our novel thrombus imaging agent, will be the subject of an oral presentation at the Radiological Society of North America (Oak Brook, Illinois) later this month."
Chinese device firm sets $100M notes sale
China Medical Technologies (Beijing) reported a proposed offering, subject to market and other conditions, of $100 million principal amount of convertible senior subordinated notes, due 2011, to qualified institutional buyers. The company also will grant the initial purchaser an option to buy up to another $25 million principal amount of notes to cover overallotments. Concurrent with the offering, the company plans to enter into a simultaneous share repurchase program of about $30 million.
China Medical said it intends to use the remaining proceeds for general corporate purposes and for the acquisitions of businesses, products and technologies that it says will complement its existing business.
China Medical will be responsible for development costs and will retain the related intellectual property.
China Medical also reported it has entered into a 10-year collaboration agreement with the Chinese Academy of Sciences Institute of Acoustics (Beijing) to establish a laboratory for developing acoustic medical devices.
China Medical manufactures products using high-intensity focused ultrasound for the treatment of solid cancers and benign tumors and advanced in vitro diagnostics products using chemiluminescence technology, to detect and monitor various diseases and disorders.
License given for diagnostic
Innate Pharma (Marseille, France) has signed a license agreement with U.S.-based diagnostics company Clinical Data (Newton, Massachusetts), granting it exclusive rights for the development of a predictive pharmacogenomic test for responsiveness to a treatment by cytotoxic monoclonal antibodies such as rituximab. The test will be based on the determination of variants of the gene coding for the Fc-gamma-IIIA receptor, for which Innate Pharma owns exclusive intellectual property rights.
Innate Pharma CEO Hervé Brailly indicated that the company did not "expect significant financial repercussions in the short term." He pointed out that, while the "individualization of immunotherapy treatments with the help of predictive markers is at the heart of Innate's development strategy, we still need to rely on the expertise of a specialist in pharmacogenomic tests for the implementation of this type of predictive test."
Clinical Data is a supplier of molecular and pharmacogenomics services and genetic tests, was not only a "reference player in this sector," but also an "industrial partner capable of developing and commercializing this type of test in optimal conditions," Brailly added. Studies indicate that a test based on the Fc-gamma-IIIA receptor predicted how 90% of patients suffering from non-Hodgkin's lymphoma will respond to treatment with rituximab.