LONDON _ Biotechnology companies will be the first to feel theimpact of the European Medicines Evaluation Agency (EMEA)which opens its doors for business today.

The EMEA, based here, will manage drug licensing in the EuropeanUnion (EU) both for humans and animals. The Council of Ministersapproved the final formal stage in Brussels yesterday, allowing theagency to begin to accept applications.

Under the EMEA's new procedures, companies will no longer needto obtain product approval in different European countries. Throughits `centralized procedure' the EMEA will approve the use of someproducts. Alternatively, a `decentralized procedure' will mean thatproducts approved in one EU country will automatically be approvedfor sale in one or more member countries "by means of a recognitionof the original authorization," said Fernand Sauer, EMEA executivedirector.

At the inauguration of the EMEA, Sauer described the new Europeanregistration system as "an outstanding step toward the establishmentof a unified market for medical products. It tends to promote the freecirculation of pharmaceuticals within the EU while reinforcing theprotection of public health."

The EMEA will have its biggest impact on medicines derived frombiotechnology. The centralized procedure became compulsory forbiotech products at the beginning of the year. Companies with "otherinnovative new products" or novel compounds can also elect to usethe procedure.

During a transition period until 1998, manufacturers of conventionalpharmaceuticals can opt for either the centralized or decentralizedprocedure.

Applications under the new system will be submitted directly to theagency in London. The EMEA will communicate the opinion of itsscientific committee to the applicant, the Commission, the EU'sadministration in Brussels and the members states.

Sauer said that, "The single evaluation undertaken under thecentralized procedure and the complementary evaluation under thedecentralized procedure clear the way for pharmaceutical firmstoward a significant reduction in research and administrative costsrelated to the submission of applications."

The remit of the EMEA calls for it to provide member states and theEU's institutions with advice on questions relating to the quality,safety and efficacy of medicinal products for human or veterinaryuse. The agency is responsible for coordinating the scientificassessment of products subject to the Community's marketauthorization procedures. A further role of the EMEA is to makesure that the manufacturers and suppliers of medical productscomply with EU legislation covering manufacturing and laboratoryand clinical practice.

Pace Of Licensing Will Not Quicken

John Sime, director of the U.K. BioIndustry Association, welcomesthe EMEA as "good news for us in Britain. Having it here improvesour access and understanding of the minutiae of the system," he toldBioWorld.

Sime does not expect the agency to do much to accelerate the pace oflicensing in Europe. "The rate at which things get approved inEurope will depend much more on directives on work that precedessubmission," said Sime. For example, he points to patents andregulations governing the release of genetically modified organisms."The fraction of time that a product spends in the EMEA might notbe decisive," said Sime.

Andy Richards, pharmaceutical business development director ofChiroscience Group plc, Cambridge, welcomes the new agency andits arrival in the U.K. He told BioWorld, "it is obviously of greatbenefit. It turns Europe into more of a homogeneous market fornovel pharmaceuticals." However, Richards anticipates that "it isgoing to cause some problems" in the short term. "No one knowsexactly what it is going to be like."

Richards expects the EMEA to act as a magnet for pharmaceuticalscompanies that want to establish a presence in Europe. "There is nodoubt that many companies are going to set up offices here to beclose to the EMEA."

Virginia Bottomley, Britain's Secretary of State for Health, said atthe launch of the agency: "The EMEA will be an added andimportant incentive for overseas pharmaceutical companies to investin the U.K. Companies based here will have rapid access to theEuropean market because the agency will streamline the licensing ofmedicinal products across the EC." The British government hastaken the opportunity of the EMEA's location in London to launch acampaign to attract pharmaceuticals companies, particularly from theU.S. and Japan, to set up in the U.K. (See BioWorld Today, Dec. 21,1994, p. 1.)

The EMEA is governed by a management board, with two membersfrom each member state, along with two appointed by theCommission and two by the European Parliament. Two scientificcommittees will advise the agency _ the Committee for ProprietaryMedicinal Products (CPMP) and the Committee for ProprietaryVeterinary Products (CPVP).

Agency Will Be Staffed With 250 Employees

Funds for the EMEA will come partly from the Community andpartly from fees paid by the pharmaceuticals industry. Thepermanent secretariat in London will build up to 100 by the end ofthe year and 250 by 1999. The provisional budget for the agency isECU 26 million ($32 million) for 1995. The EU points out that thecombined cost of Europe's national authorities is now more thanECU 250 million ($300 million) a year. It expects the new system tobe 10 to 15 percent less expensive than the cost of applying in allmember countries in the EU.

Companies will pay up to ECU 140,000 ($173,000) for approval of ahuman medicine. The EMEA will reach a decision on applicationswithin 210 days. There will then be a 90-day period for Brussels toendorse the decision. During this period member states will have 28days in which to raise "any new important issues."

The speed of the centralized system "should make us quitecompetitive with the national agencies, which don't make anypromises [on timetables]," Silvia Fabiani, spokesman for the agency,told BioWorld.

Fabiani said that the agency does not know when it is likely toreceive its first applications. She does not, however, anticipate amassive flood of biotech applications, pointing out that during thepast five years just 16 bioproducts have received approval for use inEurope. n

-- Michael Kenward Special To BioWorld Today

(c) 1997 American Health Consultants. All rights reserved.