BioWorld International Correspondent

BRUSSELS, Belgium - The European biopharmaceutical industry has found itself in the middle of a political fight over pricing, in the wake of the meeting in Brussels in late September of the European Pharmaceutical Forum.

The industry's pleadings for European pricing systems that can promote research are being countered by energetic opposition from health insurance funds, and even from within other sectors of the pharmaceutical industry itself.

The European biotechnology association, Europabio, has been reinforcing its arguments for greater price freedom, better reimbursement systems and stronger intellectual property protection. This month, it is organizing intensive lobbying contacts between its membership and the key figures in the European Union institutions - senior diplomats, officials and members of parliament who are in a position to influence upcoming changes to EU rules on everything from research funding to clinical trials on advanced therapies.

The European Federation of Pharmaceutical Industries and Associations also has joined the chorus, setting out the case for equitable approaches to assessing the value of new medicines. "The evaluation systems often remain a lottery at national level and are utilized with the goal of restricting choice," EFPIA said Oct. 4. One of the key industry objectives is to ensure that the growing trend toward health technology assessment is not used as an arbitrary device to keep innovative medicines off national markets.

But the case is coming under systematic attack. The two umbrella organizations of social health insurers in Europe, the Association Internationale de la Mutualité and the European Social Insurance Platform, which between them represent 38 social health insurance organizations across Europe, have been delivering briefings that attempt to undermine the industry's positions.

"Prices of new medicines are becoming unaffordable, and national cost-containment practices are necessary," said the insurance groupings. They turn the argument for clearer evaluation rules against the industry itself. "It is difficult to take rational pricing decisions as long as the relevant cost components and allocation for research and development costs and marketing remain a black box," they said, demanding "more transparency on the relevant price components of pharmaceuticals."

The sickness funds also rejected industry claims that better prices mean more innovation. They said the EU now has one of the most generous incentive and reward systems in the world for pharmaceutical research, yet "these major incentives and rewards do not seem to encourage the European pharmaceutical industry to provide new patient-driven innovative' products." The protection of intellectual property rights "is detrimental to competition," said Maurice Duranton, president of the Association Internationale de la Mutualité.

A similar assault has been directed into the innovative industry's arguments by the European Association of Euro-Pharmaceutical Companies, which represents more than 70 companies or associations of parallel distributors of medicines in Europe. Intellectual property protection needs no strengthening, it said in an early October statement: "Pharmaceutical inventions are more protected in Europe than in the U.S., with longer data exclusivity and patent extension periods." It added that "industry arguments that European prices are too low, putting European firms at a disadvantage compared to companies in the U.S., should be regarded with suspicion."

EU Tide Still Running Against GM Crops

Two of the European Union's official bodies are readying themselves to call for an EU-wide right for territories to opt out of admitting GM crops.

"Territories should have the right to proclaim themselves GMO-free areas," according to a report adopted Oct. 6 by the sustainable development committee of the EU's Committee of the Regions. The draftsman of the opinion, Piero Marrazzo, president of the Lazio region of Italy, has won the committee's support for his view that mixing GM and non-GM crops has environmental and health repercussions. Austrian Karin Scheele, who is drafting the European Parliament's opinion on new rules on genetically modified food and feed, indicated full support for the opinion. "Member states have to take measures to safeguard the coexistence of genetically modified, conventional and organic crops," she said, arguing that "the prohibition of the cultivation of GMOs in certain geographically restricted areas should be allowed as one appropriate measure."

EU Pushing To Overturn Austrian GMO Ban

The European Union is trying to overcome the ban imposed by Austria on the marketing of two Monsanto genetically modified maize varieties, MON810 and T25. EU officials decided Oct. 9 to ask the EU Council of Ministers to oblige Austria to lift the bans, introduced more than five years ago. If ministers back the plan, Austria would have to repeal its national ban at the latest 20 days after it is formally notified of the decision. The EU council will be asked to decide at a meeting later this year, and if it fails to muster a clear majority within three months, EU officials will then be entitled to make a decision on technical rather than political grounds.

Six other bans were invoked by other member states around the same time, during a period of widespread resistance to biotechnology, affecting Bayer's Bt176 GM maize and two oilseed rape varieties, Ms1Rf1 and Topas. EU experts subsequently rejected the member states' justifications for their bans, and in June 2005, EU officials asked the council to overturn them - but ministers voted to let them stand. Since then, officials have re-consulted experts, including the newly established European Food Safety Authority, which also concluded that there was no information that constituted new elements of risk. But now the authorization applications for all the other products have been withdrawn.

Belgium To Boost Biotech Start-ups

The Belgian government has won praise from the biotechnology industry for introducing legislation providing favorable conditions for start-ups. Partly in response to a longstanding campaign by the European biotechnology industry support the concept of the "young innovative company," a change to Belgian company law introduces exemptions that could halve employment taxes for newly established firms with less than 50 staff members that invest 15 percent of turnover on research. A government order implementing the law is expected to be issued this month.

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