BioWorld International Correspondent
BRUSSELS, Belgium - Impending changes to European Union antitrust rules are worrying European biotechnology companies, which fear that new hurdles will impede companies that want to work together in high-tech research.
The grouping of Emerging Biopharmaceutical Enterprises (EBE) said that some of the envisaged amendments would trap too many licensing and cooperation deals in the regulatory net. And other changes could create uncertainty among investors and potential partners.
"The agreements underlying these collaborations must be reliable and legally certain," the group said. "The risk of uncertainty could deter potential licensing partners."
The anxiety has been provoked by EU moves to update its regulation, giving block exemptions to certain technology-transfer deals. Although industry lobbying has won improvements since an initial draft released last October, which "posed serious problems in terms of company cooperations and licensing agreements," the latest version still presents issues that could negatively affect the innovative pharmaceutical industry in Europe, EBE told BioWorld International.
Restrictive new definitions would disqualify many current cooperation projects from automatic clearance under the block exemption; instead, they would be obliged to win individual clearance from the EU's competition authorities - threatening at best, delay, and at worst, abandonment. For instance, the new rule would lower the market share thresholds, thus capturing more agreements and threatening to render void many agreements already negotiated in good faith. EBE has told the EU it wants to see the thresholds raised and adjusted so as to focus more on agreements that are potentially anticompetitive. Other eligibility criteria for automatic clearance for licensing deals are also too onerous, the EBE said, warning that the envisaged requirements for substitutable technologies to be available are likely to be more demanding than in the U.S., leaving European biotechnology firms at a disadvantage.
EU Blocks GM Corn
National experts from Denmark, Greece, Italy, Austria and Luxembourg voted against authorizing a new genetically modified crop for use in Europe when the case came up for review in Brussels. Germany abstained.
Consequently, the application - for biotech corn, known as NK603 - failed again. The application now will be referred to EU ministers for them to decide whether to authorize the import and processing of the product. The Council of Ministers can either adopt or reject the application, by a majority vote. But if ministers fail to reach a decision within three months, the matter can then be dealt with by senior EU officials - who have indicated their support for the application. If authorized, the maize, which has been modified for increased tolerance to the herbicide glyphosate, would be clearly labeled as containing GM material. It would be allowed for import only after the new EU rules on GMOs enter application in mid-April and after the authorization for food uses of NK603 has been granted as part of the new EU GM Food legislation.
EU Ministers Review Germany's GM Coexistence Plans
The European Union's agriculture ministers this week examined Germany's new legislative plans on coexistence of genetically modified crops with conventional and organic crops and how civil liability is to be apportioned. A Feb. 11 draft law now before the German parliament and due to be adopted in the fall provides for a publicly accessible register of land cultivated with GMO seed, strict surveillance measures and a code of good practice with detailed rules for specific crop varieties. That is one of the first measures by an EU member state to legislate in the area and might set precedents for the rest of the EU.