BioWorld International Correspondent

BRUSSELS, Belgium - Doubts over the merits of gene technology are troubling European biotech executives as they return from their traditional summer break. The coming weeks could bring tough debates in the European Parliament over advanced therapies, and a long list of criticisms already has been tabled by skeptical politicians.

Proposed new European Union rules on advanced therapy medicines will be under intense discussion prior to a major debate in Strasbourg, France, in October. The proposals aim to improve patients' safe access to gene therapy, somatic cell therapy and tissue-engineered products, by creating a harmonized system for gaining EU market access.

A right-wing Polish member of the European Parliament, Urszula Krupa, who is a physician, has shelved amendments aimed at tightening controls on advanced therapies. She said that the EU needs to do more "to prevent improper use - particularly in ethical terms - being made of advanced therapies." Her amendments, which are likely to receive strong backing across the political spectrum, also emphasize the need for any new rules to focus on protecting "individual well-being" - since, she said, "in connection with treatment methods that are so innovative and of such importance to health, account should be taken of individual well-being." Similarly, she wants the rules also to take account of the "ethical significance of advanced therapy medicinal products," with proper emphasis "placed on the significance of bioethical principles."

Even the parliament's draftsman on the subject, Slovak Miroslav Mikol sik, who is also a physician, wants tougher controls. For instance, he is demanding that procurement of tissues and cells must be carried out on a nonprofit basis. "Rapid developments in biotechnology and biomedicine must not be allowed to compromise the protection of fundamental rights," he said, to justify his demand. "Standards should be met, especially for tissue- and cell-based advanced therapy medicinal products as highly innovative new products."

Critics: Bayer Should Pay To Test GM Rice

The costs of testing European food for contamination with Bayer's unauthorized GM rice should be met by the company, insisted the environmentalist organization Friends of the Earth Europe. In the wake of the recent EU action to protect consumers against imports from the U.S. of rice containing traces of the experimental rice, the organization's GM campaigner, Clare Oxborrow, said, "When incidents like this happen, the industry must be forced to accept liability."

EU member states now are obliged to carry out testing of foods on their shelves. European authorities have published the official protocol for European laboratories to follow when testing foods for the GM rice, but have left the extent of testing to the discretion of each member state. However, countries will have to pay for the testing themselves, and each individual test can cost as much as €200 (US$220), said Friends of the Earth Europe. "European taxpayers must not be made to pay," it said. "Instead, Bayer, the biotech company responsible for this pollution, must take full responsibility for its incompetence and foot the bill."

The EU's testing protocol, which sets out a construct-specific detection method using a real-time PCR assay, reflects the situation as of Aug. 31. But its testing center said it will continue to investigate the product, LLRICE601, particularly with respect to its molecular structure and to the possible occurrence of false-positive and false-negative test results, and will update the methods as soon as the need arises.

Meanwhile, a shipment of rice suspected of containing the illegal GM rice is being held in the Netherlands while Dutch authorities carry out testing.

The controversy over contamination of European rice imports with unauthorized GM strains intensified Sept. 5, with the revelation that traces of a GM rice from China had been found in Germany, France and the UK in the course of testing by Friends of the Earth Europe. The environmental group's spokesman, Adrian Bebb, said: "These incidents must be prevented from happening again. Consumers in Europe deserve better than panic measures each time the latest crisis breaks. We need a radical overhaul of food testing in the EU to stop illegal and potentially unsafe genetically modified foods from entering the food chain."

Polish Warnings On 'Trojan Horse' Of Biofuels

The so-called International Coalition to Protect the Polish Countryside has launched a new anti-GM campaign. The organization, which earlier this year ran a high-profile but unsuccessful Europe-wide campaign to ban GM-crops, now is aiming to head off any European attempts to use biotechnology to help meet the energy gap.

"The new interest in the agricultural production of bio-fuels opens the door for GM oilseed rape and other GM seeds to be imported into European countries for the purpose of processing into biofuels. At first glance, this may not look like a problem, but the reality is that it can be a 'Trojan Horse' for contaminating the seed chain and by-passing existing controls," it warned at the start of September. Its first target is the Bio Fuel Act currently under consideration in Poland.

"There is a serious danger that the passing of this act will allow into Poland large consignments of genetically modified oilseed rape seeds (and possible other GM seeds in the future) intended for processing into bio-fuels in Polish factories. If these imports are accepted, there is a strong likelihood of cross-contamination occurring through spillage and through the intentional or unintentional mixing of conventional and GM seeds," it said in a letter sent to the Polish President Lech Kacynski last week.