BRUSSELS, Belgium  European Union (EU) biotech rules are under attack again  this time from the European biotech industry itself.

European agriculture, the environment and the consumer are going to be prevented from benefiting from new varieties of crops, unless the EU changes its approach to updating rules on biotech product release, said Tim Stocker, chairman of a European biotech industry task force. He said proposed changes to a 1990 EU directive are inadequate, because they offer authorizations which are of too short duration, and they give no assurance that decisions will be based on science.

The workings of EU Directive 90/220/EEC on deliberate release of genetically modified organisms (GMOs) have come to be regarded as ponderous even by European regulatory authorities. That is why the European Commission proposed changes to the rules in February this year. But, said Stocker, speaking on behalf of the industry association, EuropaBio, the proposals for change do not go far enough. He lists among the problems in the current rules the lack of time lines  ¿and when they are indicated they are not followed,¿ he said. Other problems include inconsistent decision-making and the inability of regulators to keep pace with the number of applications, he said, adding that EU legislation originally intended to make possible a science-based risk assessment ¿has been used for other political purposes¿ and as a result the biotechnology industry ¿has no clear regulatory route map to follow.¿ In Stocker¿s view, the procedures ¿do not enable products which are safe to be introduced with the degree of certainty which is required for industry to invest in the new technology.¿

EuropaBio concedes that the commission is attempting to address some of the difficulties, with some improvements on time lines and some move towards a streamlined procedure based on the principle that, when a GMO is similar to another already approved, it can be processed through a fast-track procedure.

But the planned improvements are neutralized because authorizations will be valid for seven years only, said Stocker. ¿The plant breeding industry cannot work with such restraints,¿ he said. ¿The GMO is integrated into a variety from which continuous breeding takes place over many generations.¿

EuropaBio also has concerns that the proposed changes will impose an excessive and even unlimited monitoring burden on innovation. Monitoring, it says, must be ¿targeted only to those issues which could constitute a risk from the GMO which is being authorized. There must be a link between the monitoring required and the safety assessment of the GMO. Monitoring should be restricted to possible adverse effects which may derive from the genetic modification itself. It should be limited to what is necessary for a company to fulfill its legal obligations under the directive.¿ Worst of all, said Stocker, the new proposal ¿does not address the problem of the decision-making procedures. Industry will have no confidence that decisions will be based only on real knowledge of the safety issues.¿

The pressure to toughen up the directive comes in large part from the consumer lobby in Europe, and from European Consumer Affairs Commis sioner Emma Bonino. She claims personal responsibility for introducing some of the tighter controls into the commission draft. ¿I have strongly asked for and obtained some of the changes¿ to the proposal, she said, ¿such as compulsory consultation of a scientific committee, monitoring GMOs and their effects once they are on the market and are circulating free in the environment, and re-evaluation of authorizations after seven years.¿ She said industry should ¿totally support¿ these amendments.

Meanwhile, the European Commission forecasts for growth in the biotech sector are strong, but not as strong as the industry¿s. European Research Commissioner Edith Cresson told industrialists at the First European Forum for Innovative Businesses in Vienna that the European market in biotechnology products should soon be worth more than ECU 100 billion (US$118 billion) every year. By contrast, EuropaBio speaks of the value of products and services using biotechnology in Europe reaching ECU 250 billion a year by 2005, providing more than 3 million jobs. The commission said its current 700 businesses and 30,000 jobs represent ¿considerable scope for growth,¿ and Cresson gave a personal commitment to support giving ¿new impetus to a Europe of innovation, of entrepreneurship and of the creation of more and higher skills.¿ Her remarks indirectly echoed one of the conclusions of the recent EuropaBio conference in Brussels, at which an official from St. Louis-based Monsanto Corp. remarked  at the end of the final session on business development and marketing  that at the EU level, administrations are ¿distant, uninformed, and not linked to the practical realities.¿

No Comments