BRUSSELS, Belgium - Yet another attempt at resolving the European Union's (EU) embarrassment at member states' refusal to comply with its own biotechnology legislation led to another decision deferral when European environment ministers met last week in Luxembourg.

The ministers, who make up the EU Environment Council, looked again at Austria and Luxembourg's prohibition of the sale and use of genetically modified maize - Basel, Switzerland-based Novartis AG's product modified for insecticidal properties with the Bacillus thuringiensis endotoxin gene and for increased tolerance to the herbicide glufosinate ammonium. (See BioWorld International, Feb 18, 1998, p. 4, and April 22, 1998, p. 1.)

The product was authorized for marketing in the EU by a European Commission (EC) decision in January 1997, but Austria and Luxembourg raised objections on scientific grounds, and decided subsequently to ban its sale and use.

The EC - responsible not only for new EU rules, but also for ensuring that EU rules are obeyed - has won the backing of its scientific committees on the points at issue, and has asked the Environment Council to end the bans.

But members of the Environment Council simply glanced at the matter. They concluded, “The debate has allowed a preliminary assessment of positions of delegations on the EC proposals.“ What this really means is that the member states decided not to push the matter very hard. In fact, they are not under any great time pressure on this question, since the EU rules allow them until mid-September to take a view.

Meanwhile, they also are waiting for the opinion of the European Parliament, which is examining the question and is expected to give its final view by mid-July.

Delay Over Licensing Rule Changes

The Environment Council also took a leisurely approach to another biotechnology dossier the EU has been toying with for more than two years - reform of EU rules on licensing biotechnology products for marketing, which also is referred to as the deliberate release into the environment of genetically modified organisms (GMOs).

The EC finally proposed changes to the 1990 EU legislation in February this year, after long pressure from industry for a more user-friendly regulatory framework in Europe.

The EC said its proposals will “contribute to the establishment of a comprehensive regulatory framework to ensure a high level of safety for the environment and human health, and will increase transparency while preserving the necessary flexibility, taking into account experiences gained with this legislation and other related instruments.“

What the proposals actually aim to do is speed up the authorization of low-risk products and remove some of the uncertainty from the context in which European biotechnology research is conducted.

The main elements include establishing common principles for risk assessment; introducing a classification system for experimental releases; providing marketing authorizations for a fixed period of seven years; monitoring products after they are on the market; and clarifying and broadening labeling requirements.

At the same time, the new rules would impose some new constraints - such as mandatory consultation of scientific committees on matters that effect human health and the environment, and increasing the responsibility of the Environment Council.

At its June 16 meeting, the Environment Council looked at how clear the proposed amendment was, and what its scope would be. In particular, it considered how adequate the proposed procedures would be in terms of protecting the population and the environment; how far they responded to the need for risk assessment, monitoring and ethical issues; and how transparent the procedures would be in terms of the information they would make available to the public through labeling and in public discussions.

The ministers acknowledged that public involvement in the biotechnology debate is an increasingly important factor. “The continuing debate between consumers, industry and regulators has demonstrated that the establishment of a transparent, consistent and comprehensive regulatory framework in the field of biotechnology is very much needed,“ they declared. The ministers said revision of the existing legislation could be an answer.

Despite all the expressions of anxiety over the urgent need to protect everyone and everything, the ministers decided that this will be no more than a first-policy debate, and that they will take the matter no further until they receive the opinion of the European Parliament, which is scheduled to present its report in October 1998.

Only then will the full Council of Ministers - still the dominant rule-making body in the EU - try to arrive at a common position. This probably will occur at the Environment Council meeting scheduled for December 1998.

EU Biotech Patents Rule Wins Final Approval

At the same Environment Council meeting last week, ministers also adopted without discussion the directive on the legal protection of biotechnological inventions, which has been making its way through the EU consultative machinery for the last three years.

In the end, the directive received its final stamp of approval only by a majority vote: the Netherlands delegation voted against the proposal; the Belgian and Italian delegations abstained.

But because Europe's Byzantine voting rules allow for what is known as “qualified majority“ decisions, the opposition of some smaller states and one large state was not enough to sabotage the measure at this last hurdle.

The aim of this much fought over proposal is to establish harmonized, clear and improved standards for the protection of biotechnological inventions so as to advance innovation and the competitiveness of EU science and industry in biotechnology.

The new rule systematically adapts the rules of patent law in the biotechnology field in order to ensure that patent legislation is more effectively applied in this area. *