Local view for "http://purl.org/linkedpolitics/eu/plenary/2006-06-13-Speech-2-253"
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"en.20060613.27.2-253"2
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".
The Commission’s competition enforcement priorities in the pharmaceutical sector have two key objectives: one is to tackle intra-brand competition between the producers of patented prescription products and the parallel importers of those products; the other is to promote competition in innovation for patented medicines between the pharmaceutical producers, which has declined in Europe in the last decade, and to encourage intra-brand competition from generic substitutes after patent expiry. That should, in time, contribute to ensuring a wider choice of both patented and generic pharmaceutical products to European patients at affordable prices. Due account is taken of the need for the industry to recover its research and development costs, given the industry’s heavy dependence on innovation for its further competitiveness. In that context, the honourable Member can be assured that the Commission is not circumspect about rigorously applying the anti-monopoly provisions in the pharmaceutical sector, for generic competition is an area which has suffered from under-enforcement in the past. However, the importance of the generic segment for the provision of affordable medicines in the enlarged Union cannot be ignored. That is why the Commission will give greater priority to competition in the generic sector in the immediate future.
On the issue of parallel trade, the Commission has always taken an active approach to combating restrictions on parallel trade in pharmaceuticals. In the Commission’s opinion, parallel imports are a legal form of trade between the Member States, constituting an alternative means of supply in the import countries.
The Commission is aware of the supply quota systems put in place by several pharmaceutical companies. Under those systems, pharmaceutical companies unilaterally allocate a quota of medicines to their wholesalers. In principle the quota covers domestic demand for the medicines in question in a particular Member State.
The European courts have held that such unilateral supply quota systems are not within the scope of Article 81 of the EC Treaty when there is not enough evidence that they are the result of an agreement with wholesalers. However, another type of practice aimed at curbing parallel trade such as ‘dual pricing systems’ – which, as you know, are systems where prices differ according to whether the product is for local consumption or for export to the other Member States – has been held to infringe Article 81 in, for example, the Glaxo-Wellcome decision of May 2001.
The Greek national competition authority has initiated proceedings against restrictions on parallel trade on the basis of Article 82, which prohibits the abuse of a dominant position. There are also parallel civil litigation proceedings pending in Greece, dealing with the same matter. The Commission is monitoring these developments closely.
Article 152 makes clear that the organisation and the delivery of health services and medical care are the responsibility of the Member States. The competent national authorities are free to make their own decisions on pricing and reimbursement for pharmaceuticals, provided that these decisions are made in a transparent manner and do not create barriers to trade.
The Commission understands that in Poland the price of reimbursable pharmaceuticals is subject to a Ministry of Health decision following representations from the industry. In discharging that duty, the Polish authorities could and do use prices in other EU Member States – including low-price countries – as a reference point.
It should also be noted that the Commission has recently launched a project under the pharmaceutical forum, which addresses the issue of national pricing and reimbursement practices. That project will take account of the interests of patients, Member States, wholesalers, manufacturers and other stakeholders."@en1
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