BioWorld International Correspondent

BRUSSELS, Belgium - Steen Riisgaard, president and CEO of Novozymes and chairman of EuropaBio, set out the European biotech industry's policy priorities to two top European Union officials Monday.

In an unprecedented face-to-face meeting with Commission Vice President Günter Verheugen - responsible for industry affairs - and Commissioner Janez Potocnik - responsible for research - he listed the issues and the arguments that keep industry bosses in Europe awake at night.

The EuropaBio chairman focused on the value of innovation, and spelled out the problems that the industry suffers because of difficulties in market access and approval for biotech products. He also emphasized the urgent need to make the recently adopted advanced therapies regulation fully effective.

The EU currently is implementing a midterm review of its 10-year strategy for life sciences and biotechnology, and industry leaders are seizing the opportunity to drive home the need for a coherent policy across Europe, on everything from clinical trials to the development of a patient-centered public health care system.

Verheugen recently assured EuropaBio that he was sensitive to the industry's anxieties over biopharmaceutical product pricing, which remains an entirely national matter, and results in uneven prices for the same product across Europe's 27 member countries. He promised that during 2008 he would aim to provide a new European framework to guide national authorities when they are putting a value on pharmaceutical products.

Biosimilars Turn From Trickle To Stream

The latest figures from the European Medicines Agency show steady growth in marketing authorization applications from "biosimilars" - as generic biotechnology products are termed in Europe. There were eight applications in the first half of 2007 alone, and the agency expects another eight in the second half. That is more than five times the level of the previous year.

The trend demonstrates that the innovative European biopharmaceutical industry has failed in its strenuous attempts to limit the growth of generic biotech products. Its arguments have not prevailed that those products are so sensitive that copies of them are undesirable for reasons of safety and efficacy.

However, the European industry has welcomed some small relief in the spread of biotech generics from another quarter. Spain's ministry of health and consumer affairs introduced in late September a ministerial order that prevents one biological medicine being substituted automatically for another in the dispensing of prescriptions. The order specifically excludes biological medicines, due to their particular therapeutic or pharmacological characteristics, from substitution by pharmacists without express permission from the prescribing physician, in the interests of protecting patients.

EuropaBio, the EU association for bioindustries, welcomed the rule as recognition that biological medicines are complex and cannot be substituted automatically for administration to patients.

"We applaud the new Spanish regulation that protects patient safety. It is important that the biotechnology industry has an appropriate regulatory framework in place, which provides clear guidance to pharmacists and patients alike," commented Andrea Rappagliosi, chairman of the Healthcare Council, EuropaBio.

The Spanish rule follows a similar law adopted by France earlier this year, which stipulates that biotechnology-based reference products and biosimilars are not identical and therefore such reference product cannot be substituted at the pharmacy level by a biosimilar product automatically.

"Spain and France are providing leadership on this issue by pursuing patient-centered policies. We hope other countries will also provide such clear guidance," Rappagliosi added.

Stalemate On Four More GM Products

A key European Union health committee has failed to deliver an opinion on marketing authorization applications for four new GM products: three maize varieties from Monsanto and a potato from BASF. The national experts were deadlocked in their meeting Oct. 10 and unable to produce the majority opinion needed for approval or rejection.

In what has become a familiar pattern, EU officials will transfer the applications to a ministerial-level meeting in the EU Council. Since the voting pattern in the council usually reflects the position of national experts, it is likely the council also will be deadlocked. If ministers fail to decide in the next three months, EU officials will be entitled to approval the products themselves.

The European Food Safety Authority already addressed all safety concerns and found there to be no risk to human or animal health or to the environment from the products. However, as in the past, the risk is that products that obtain authorization through the default procedure subsequently encounter problems in accessing the market of the countries that were opposed to them.