| Author (Person) | Davies, Eric |
|---|---|
| Publisher | ProQuest Information and Learning |
| Series Title | In Focus |
| Series Details | 24.10.02 |
| Publication Date | 24/10/2002 |
| Content Type | News, Overview, Topic Guide | In Focus |
|
MEPs have voted to support Commission proposals to reform EU legislation on pharmaceutical products. On 23 October 2002 the European Parliament voted on three proposals:
Although all three proposals were adopted, MEPs voted to amend each of them, causing the Commission to give the decisions only a 'qualified welcome' and to express the hope that 'agreement on a series of important issues' might be reached at some future date. According to the Commission, the proposals 'aim to strike a balance between a high level of health protection for European citizens and the need to boost the competitiveness and innovative capability of the European pharmaceutical industry. These proposals will also facilitate the free movement of medicines and pave the way for EU enlargement.' Whilst supporting the draft Regulation laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use, MEPs adopted amendments 'designed to improve transparency and access by consumers to information on new drugs.' MEPs would like to see a database of 'neutral information' on drugs made available free of charge to EU citizens, enabling people to compare different products, and would like to see greater incentives for pharmaceutical companies to develop new drugs to combat poverty-related diseases. Also, within five years of a new drug being placed on the market, pharmaceutical companies should, according to MEPs, provide an information leaflet which would include the wording 'Newly authorised medicinal products. Please notify any adverse reactions'. Under the proposal, the role of the European Medicines Evaluation Agency (EMEA) would be enhanced (the Regulation is not, as its title suggests concerned with 'establishing' the Agency - EMEA was established in 1993). Although the draft Directive amending Directive 2001/83/EC on the Community code relating to medicinal products for human use was overwhelmingly approved, MEPs rejected a Commission proposal for a pilot project to allow information to be provided on new drugs to treat diseases such as AIDS, asthma and diabetes, causing Commissioner Erkki Liikanen to say 'Our proposal would not allow non-solicited advertising for such medicines as is the case in the United States - Nothing is further from our minds than introducing advertising for prescription medicines in Europe. What we are proposing is to allow Europe's patients to obtain appropriate and authorised information if they ask for it.' Parliament also voted for a 10-year period of patent protection - extending to 11 years in some cases - 'with protection for the results of clinical tests during this period'. In voting to support the other draft Directive, relating to veterinary medicinal products, MEPs called for an amendment 'to exempt horses used for sporting and leisure purposes from stringent new rules' and to 'allow vets a certain amount of leeway in issuing drugs'. Welcoming the votes, the European Commissioner responsible for Enterprise, Erkki Liikanen, said:
The proposals must now be endorsed by the Council of Ministers before being put to a second reading in Parliament. Links: Eric Davies MEPs voted on 23 October 2002 to support European Commission proposals to reform EU legislation on pharmaceutical products. |
|
| Subject Categories | Business and Industry |
