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Why should the length of data protection for medicines not be extended?
Leaflet N°9
09 September 2002

Medicines in Europe Forum believes that the strengthening of patent protection over the past 12 years, together with the proposed prolongation of data exclusivity would jeopardise health budgets and mutual health insurance systems.


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The industrialised countries have gradually implemented a patent system with exclusive rights of exploitation so as to encourage private research, and allow the inventor to secure a return on investments. These exclusive rights giving in practice an almost total freedom of pricing, the length of actual protection is a key element in the balance between industrial interest and that of the public.
Under pressure from pharmaceutical firms, other types of exclusive marketing rights have been introduced, such as Supplementary Protection Certificates, and data protection that prevents the use of data in the simplified marketing applications for generics.

In some countries outside the EU an exemption called "Bolar" provision allows a marketing application to be filed before the end of the patent period so that the marketing of the generic can begin immediately after the expiry of the patent.

The proposed Directive provides for a new harmonised 10-year period of data exclusivity, with an additional 1 year when the manufacturer provides a new clinical use. Yet half the member states only apply data exclusivity for 6 years.
This proposal would therefore delay access to lower priced generics for half the member states where the exclusivity period would go from 6 to 10 years or even 11.
Exclusivity offered in Europe by Supplementary Protection Certificates is already one of the longest in the world, up to 15 years as opposed to 14 years in the USA. Lengthening data protection in Europe is bad drafting. It will be costly to patients and insurance systems. According to the manufacturers of generic medicines, the cost to bear by the public for 1-year extension of data exclusivity will be up to 543 million Euro for the UK, 495 million Euro for Germany and 274 million Euro for France.

The Commission is planning that the patent duration being lengthened by 6-12 months whenever a manufacturer carried out a clinical trial in children.