European pharma news in brief
news from around the European continent.
Ireland is now the world's largest net exporter of medicines, with trade exceeding €9.98 billion in the first eight months of the year, up from €8.78bn in the same period of 2003, according to data published by the country's Central statistical Office.
The CSO data shows that the country imported medical and pharmaceutical products worth €1.32 billion in the period, compared with €1.50 billion a year earlier.
Germany's association of generic drug manufacturers, the DGV, has warned that the market faces an oligopoly in the medium term, with three companies - Ratiopharma, Hexal and Stada - taking a dominant position, according to a report published in Die Welt newspaper.
This says the market share of the three largest German generics firms and their subsidiaries has risen from around 30 per cent five years ago to over 50 per cent today. In June this year, their market share reached a record 51.2 per cent. This means that pricing competition in the generics sector, which the DGV says is the only economic engine for achieving savings in drug spending, is weakening and may collapse.
Germany's generics market is characterised by falling volume and growing pressure from the country's recently-implemented drug discounting regime. Competition has intensified this year particularly because 12 drugs have come off patent and are now exposed to generic competition.
In Spain, the Ministry of Health has announced that it will reduce medicine prices 4 per cent in 2005 and a further 2 per cent in 2006, and also suspend the current system of reference pricing on the grounds that it has described as 'arbitrary and inadequate'. The move has prompted claims that the research-based industry will be driven away from doing business in Spain.
The aim is save around €400 million. Moreover, a new system of reference pricing is to be introduced for 2006 that could encourage the uptake of generic drugs in Spain, traditionally a market that has resisted their use. Local reports suggest that a manufacturer submitting an application for a generic drug whose price is 30 to 50 per cent lower than the reference product will receive automatic approval.
A new pharmaceutical manual, being discussed for the third time by Italy's Agency of Pharmaceuticals (AIFA), will save €220 million a year, according to the agency. "In 2004, there was an increase in drug use, and thus an increase in spending of 10 per cent. There is no justification for this," said Health Minister Girolamo Sirchia, cited by AGI Online.
"The reality is that spending increases took place for very few drug categories, which grew significantly. All this depends on a series of factors on which we must and can intervene," he said. The new manual tries to contain growth in these categories of drugs to free up resources for innovative drugs, added Sirchia.
The government in Lithuania has approved a draft resolution on the licensing of pharmaceutical activities that complies with European Union regulations, according to Baltic Business News. The new rules provide a list of requirements and documents needed in order to obtain licenses for pharmaceuticals. They also define the duties of some types of workers in the pharmaceutical industry.
