92000E1834

WRITTEN QUESTION P-1834/00

by Hartmut Nassauer (PPE-DE) to the Commission

(31 May 2000)

Subject: Dealing with the manufacture and distribution of pharmaceuticals in the central and eastern European applicant countries, and their impact on the EU after accession

The standards applying to the pharmaceutical industry in the central and eastern European applicant states do not comply with those of the EU. Hence when these countries join, the EU will face serious problems: among them, the fact that there is no protection of intellectual property comparable to the EU standard, that existing commitments have not been met and that there is likely to be distortion of competition against EU manufacturers.

1. What will the Commission do to introduce patent protection in the central and eastern European countries and prevent patented products from being offered for sale there as generic medicines after accession, as they are at present?

2. What action will it take to deal with the following:

- To date, virtually none of the central and eastern European countries have fulfilled the commitments they made in the Europe Agreements to introduce a level of intellectual property protection similar to EU standards; such standards include the supplementary protection certificate for pharmaceuticals (SPC), which is an integral component of Community law and intended to guarantee an appropriate period of protection for pharmaceuticals in practice?

- In many central and eastern European countries there is no effective patent protection on substances for many pharmaceuticals introduced by western companies, as it was only introduced in the 1990s. As a result, imitators are already copying drugs patented only in the present Member States, before the patent expires in the EU, and are thus able to supply the markets with cheap copies?

- Low social and economic standards and unfair competition arising from the absence of patent protection are often forcing research pharmaceutical manufacturers to offer their original products there for substantially lower prices than they would if there were proper cost calculation including the total development cost?

- There are still substantial deficiencies in the central and eastern European countries in the protection of supporting documents submitted for the authorisation of pharmaceuticals?

- Standards of law enforcement and the administration of justice do not comply with EU standards in many central and eastern European countries?

- There are likely to be competitive advantages for manufacturers in many central and eastern European countries over EU manufacturers, as a result of failure to comply with international quality standards, which push up costs, and government failure to enforce them?

Answer given by Mr Verheugen on behalf of the Commission

(30 June 2000)

The Commission considers that the large majority of the Central and Eastern European candidate countries have made substantive progress in harmonising domestic legislation with the acquis in the pharmaceutical sector. However, certain shortcomings still exist.

In the context of the accession negotiations, the Community has recalled the importance it attaches to the existence of an equal level of protection of industrial property rights within the enlarged Union.

The Community has therefore suggested that a specific mechanism be provided in the accession treaty in order to prevent distortions on the market for pharmaceutical products following enlargement. According to this mechanism the holder of a patent or supplementary protection certificate (SPC) for a pharmaceutical product filed in a Member State at a time when a product patent or SPC could not be obtained in a candidate country for that product, would be able to rely on the rights granted by that patent or SPC in order to prevent the import from that candidate country (following accession) and marketing of that product in the Member State or States where the product in question enjoys patent protection or SPC protection, even if this product was put on the market in the candidate country for the first time by the SPC or patent holder himself or with his consent.

In addition, as regards the introduction of a supplementary protection certificate, the Community stressed in the context of the accession negotiations that this Regulation is an essential part of the patent legislation in the pharmaceutical sector and that it should be applied in the candidate countries as early as possible and upon accession at the latest so that all patented pharmaceutical products with market authorisation should be eligible for a SPC even if the date of the first market authorisation has already expired.

As regards the protection of supporting clinical trial data submitted for the authorisation of pharmaceuticals, the candidate countries will have to take over the relevant acquis by the time of accession. Existing obligations under the Trade-related intellectual property right agreement (TRIPs) are also relevant in this context.

As part of the accession process, the candidate countries will also have to apply the manufacturing practices and quality standards applied in the present Member States and comply with them fully at the latest by the time of accession. In fact, many candidate countries have already made good progress in this respect.

The Commission will continue to give special attention to legislative approximation as well as to the reinforcement of candidate countries administrative capacity.