| Author (Person) | McLauchlin, Anna |
|---|---|
| Series Title | European Voice |
| Series Details | Vol.11, No.41, 17.11.05 |
| Publication Date | 17/11/2005 |
| Content Type | News |
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By Anna McLauchlin Date: 17/11/05 Member states who joined the Union last year are renewing their fight against an EU law that prevents them from allowing pharmaceutical companies to market generic copies of drugs before ten years have elapsed. Meetings will begin next week between the European Commission services and the countries concerned, who argue that the law will cripple their generic drugs industries and their healthcare budgets. The new EU pharmaceutical legislation, which must be applied from this month, obliges all member states to grant a ten-year data exclusivity period for new medicines. Many new member states had much shorter exclusivity periods and protested against the legislation when it was adopted just a couple of weeks before they joined the EU in May 2004, so that they were not able to vote on it. Data exclusivity allows the maker of a drug to protect its market monopoly by preventing government authorities from granting marketing authorisation for generic manufacturers. In August this year the Commission turned down a request from seven of the new EU states - Cyprus, Hungary, Latvia, Malta, Poland, Slovakia and Slovenia - to be granted at least a ten-year transitional period for the new law to be implemented. The Commission sent a letter stating that the economic case put forward by the member states did not justify any temporary exemption. A study on the impact of the extension of the data exclusivity period, commissioned by the EU executive and based on the data submitted by the new member states, will be published in the next few days. But an official confirmed that talks would continue with some of the member states. European Voice understands that Poland, whose generic medicines industry is worth around EUR 2 billion, Hungary, Latvia and Malta are on the list. "Talks between those member states concerned and the Commission services are scheduled to begin in the very near future," he said. "There are two arguments on this," said a Latvian official. "One is the impact that this decision will have on our healthcare figures and the other is that it will damage our local pharmaceutical industry, which mainly consists of generic manufacturers." Some industry sources played down the importance of the talks. One said that the Hungarian government was simply insulted by the Commission's brush-off in August and wanted a proper consultation before agreeing to implement the law. According to figures published by pharmaceutical and biotechnology analyst Scrip in April this year, an increased use of imported brand-name drugs in the Czech Republic drove pharmaceutical spending up by 7%. The average cost of such drugs was EUR 9.10 compared with EUR 2.75 for the average generic drug and the volume of medicines sold fell by 5%, suggesting that people in these states did not have the budget for brand- name medicines. A spokesman for the European Generics Association said that he was "disappointed that the facts and figures in some member states have not been taken on board by the Commission". But the non-generic drugs companies support a harmonised ten-year exclusivity period. "We strongly hope that the Commission will convince the Hungarian government that harmonised legislation is a good thing for Hungary and the entire EU," said Krisztina Szekely from the Association of Innovative Pharmaceutical Manufacturers. EU Member States who joined the EU in 2004 are renewing their fight against the EU law that prevents them from allowing pharmaceutical companies to market generic copies of drugs before ten years have elapsed. |
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| Source Link | Link to Main Source http://www.european-voice.com/ |
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| Subject Categories | Business and Industry, Health, Internal Markets |
| Countries / Regions | Europe |
