Pharma reforms adopted, but community patent delayed
legislation comprising the new framework for pharmaceuticals, but
its failure to agree on a pan-EU patent system has undermined the
progress made in the reform package, according to Internal Market
Commissioner Frits Bolkestein.
He said in a statement that failure to take the patent strikes at the heart of Europe's ability to compete on the global stage, noting that two years ago the so-called Community Patent was put forward as 'a vital measure for boosting Europe's competitiveness by encouraging innovation'.
The main sticking point was how infringements of patents which might arise as a result of mistranslations should be treated, although the Council had agreed the principles behind the patent as early as March last year.
"It is a mystery to me how Ministers at the so-called Competitiveness Council can keep a straight face when they adopt conclusions for the Spring European Council on making Europe more competitive and yet, in the next breath, backtrack on the political agreement already reached on the main principles of the Community Patent in March of last year," he said.
Welcomed by industry
The pharmaceutical industry welcomed most aspects of the new legislation, which will have to be applied by national governments across the EU within the next 18 months.
The changes are intended to streamline the regulatory procedures for pharmaceutical registration and accelerate the availability of new products for patients, while at the same time strengthening the supervision of pharmaceutical products on the market in the interest of public health.
One component is that the centralized European procedure for the authorisation of pharmaceuticals will now be opened to more types of new medicines i.e. all new medicines intended for four therapeutic areas - AIDS, diabetes, cancer, neurodegenerative diseases - in addition to biotechnology products.
Other aspects include the harmonisation of regulatory data protection, allowing authorised generics to enter the market at 10 years, the granting of one extra year of data protection for important new uses, and new definitions of generics and of 'biosimilar' medicinal products.
The director general of the European Federation of Pharmaceutical Industries and Associations, Brian Ager, said the final compromise package does not fully meet the needs of the research-based pharmaceutical industry but it brings in important improvements in Europe's regulatory structure.
The main objection of the pharma industry is that the reform package does not go far enough to improve data protection, i.e. the intellectual property on the clinical and preclinical data aimed at proving that a new compound is safe and effective.
The legislation must now be implemented without delay, and in an appropriate manner, he said, adding that the EFPIA "will carefully monitor the implementation of the Directive and Regulation against the expectation that the long-awaited reform of the EU pharmaceutical legislation will encourage pharmaceutical research and provide more rapid access by patients to new medicinal products".
