The medical device industry is steadily mounting resistance to the European Union's planned revisions to Directive 2001/83/EC on Medicinal Products for Human Use.

Currently under debate in the European Commission, the proposals have raised red flags at the Association of British Health-Care Industries (ABHI) and Eucomed. The groups claim that the proposals, by altering the definition of medicinal products, would expand the scope of drug regulations, encroach on devices and move pharmaceuticals into a dominant regulatory position in Europe.

For instance, in the revised definition of a "medicinal product," the phrase "administered to" is replaced by "used in." The commission thereby wishes to encompass gene or cell therapies, Eucomed says, even though such new therapies are not excluded from the scope of the current definition of a medicinal product.

Further, the suggested wording could refer to an additional number of medical devices that are "used in" the patient, creating legal uncertainty and confusion with no benefits, Eucomed contends.

Revisions to the directive are reviewed by the EU on a regular basis. The latest proposal includes a new paragraph (Art. 2.2) providing that pharmaceutical legislation should prevail in cases of jurisdictional doubt. Directive 93/42/EEC on medical devices (the MDD) covers the same issue, and Eucomed questions the need to introduce a new provision on the same subject matter in pharmaceuticals law, citing that few problems have ever arisen under the current organization.

Furthermore, Art. 3 of the proposed regulation lists the product areas that do not fall within the scope of the pharmaceutical legislation; medical devices are not included.

The combination of those elements is tantamount to changing the legal basis for a variety of devices that are satisfactorily regulated today, Eucomed contends.

The association has targeted several EU politicians to try to head off the measure before it reaches the European Parliament or Council later this year. Namely, Eucomed will follow the debates around the reports by Françoise Grossetête, rapporteur for Parliament's ENVI Committee, and Mel Read, rapporteur for the ITRI Committee.

In a report from ENVI presented to Parliament, Grossetête suggested that colleagues exclude cosmetics and food items from the proposal. Industry hopes that devices can successfully be excised from the legislation in the same manner.

Comments on the ENVI report were being accepted through the week of June 17. A final version will be issued in July.

Alternatively, Read suggested that the entire definition change be eliminated, a strategy that would appease industry. Failing removal, Eucomed hopes to amend the definition and direct it primarily toward products with a pharmacological, metabolic or immunological primary intended purpose, effectively eliminating devices.

The commission will vote on the report in September before a plenary session of Parliament in October. Afterward, the proposal will reach a convention of the European Council, followed by a second reading in Parliament.

The European Commission originally adopted a proposal for a comprehensive reform of the pharmaceutical legislation in July 2001, focusing on reinforcing London's European Medicines Evaluation Agency (EMEA) and a centralized European procedure for authorization of pharmaceuticals, established and operational since 1995.

Eucomed has since emphasized that the regulatory framework for medical devices should remain completely distinct from pharmaceuticals, charging that the commission's proposal would delay patient access to technology and make products more expensive without making them safer.

Products that could be affected by the proposals include implants incorporating pharmaceuticals and other emerging technologies, such as hip replacement devices with antibiotic coats and drug-eluting stents. However, the legislation could go as far as covering basic latex gloves and contact lens solution, Eucomed leadership cautions.

The pharmaceutical revisions are also stimulating comment from FDA. "Even the issue of drug-coated stents isn't settled in Europe very well," CDRH Director David Feigal said at AdvaMed's recent device submissions workshop.

"Even through the first ones may be approved as devices, it is not at all clear that those won't be moved into regulation by the EMEA as pharmaceuticals," he continued. "The principle that is starting to be discussed worldwide is whether or not the component with the most complex public health issues and regulatory issues shouldn't be the component that drives the regulatory scheme, so I don't know if any of these things are settled anywhere in the world at the moment."

In the UK, the announcement of the merger of the Medical Devices Agency with the Medicines Control Agency on June 13 was greeted in the context of the current debates. Effective April 2003, the consolidation will not affect legislation or regulatory processes that are tailored to each sector, MDA says (¹ 'The Gray Sheet' June 17, 2002, In Brief).

The UK Department of Health cites increasing convergence in the two fields as the main reason for creating the single executive agency: "As technology develops, there are likely to be growing numbers of products that cross the borderline between medicines and devices," Heath Minister Lord Philip Hunt explained. "Some products are already a combination of drugs and devices. The boundaries will become even more blurred in the future. Through this change, the agency will be well placed to respond to the changing world of medicines and medical devices control."

The two organizations, which are both currently executive agencies under the UK DoH, will combine to form a single agency responsible for both areas. The as-yet-unnamed agency will feature novel arrangements for accountability and governance with the addition of non-executive members to the agency's board and establishment of a new post of chairman.

The idea of a joint agency has been on the backburner since 1999, when ABHI lobbied successfully against a merger. ABHI continues to contend that a single agency will have adverse effects on device costs and competitiveness of firms. Numerous trade groups have previously cautioned that such mergers portend momentum to establish a single EU health commissioner (² [A#01270130005], p. 11).

Although ABHI is pleased to accept DoH's guarantee that there will be no effect on the legislation and regulatory processes for devices, the association says it remains "very concerned about the lack of detail" pertaining to the merger, Director-General Gordon Aylward stated in a June 13 release. The association says it plans to seek representation on the board of the new agency.

Following the announcement, Eucomed called upon all European health authorities to develop a new approach for the growing variety of emerging medical technologies that elude the traditional drugs-devices divide. As examples, the trade group points to tissue-engineered bone, cartilage and skin products.

A draft directive on tissue-engineered products, currently under development by European Commission staff members, is due for review in December (³ Also see "European Commission To Review Tissue Products Draft Directive In December" - Medtech Insight, 10 June, 2002., p. 15).

The combination products issue is crystallizing at a key point in Eucomed's leadership as Maurice Wagner transitions into the director-general position. Wagner joined as head of the association in May, taking over from Michael Baker.

Wagner brings several years of experience in the pharmaceutical industry, having held legal, marketing and EU affairs positions at Roche. Since July 1996, he has served as executive director of three international associations operating within the fragrance and flavor industry - the International Fragrance Association, the International Organization of the Flavor Industry and the European Association of the Flavor and Fragrance Industry. Wagner names improving access to devices and time to market as themes for his directorship.

Combination products have forced European industry officials to reexamine the fundamental differences between drugs and devices. Eucomed emphasizes that while both treatments' uses include diagnosis, prevention, treatment of disease and investigation or modification of physiological processes, different "ways of action" preclude a singular regulatory pathway.

Device risks and impact are also of a different nature, yielding separate regulatory consequences. Device regulation is based on the "new approach," under which placing products on the market is not subject to formal authorization. Instead, conformity procedures are based on third-party certification and voluntary standards.

MDA Merger Qualms Fuel Device Industry Critique Of EU Drug Directive

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