The European drug industry is looking on with rising alarm as its American rivals pull further and further ahead in the innovation stakes.
The European Commission has a number of initiatives in the pipeline aimed at enabling Europe's industry to close the transatlantic innovation gap. The Commission's proposed streamlining of drug approval regulations is currently doing the rounds at the European Parliament. It has also set up an advisory group known as the G10 to look into the industry's other gripes.
While welcoming the Commission's efforts, industry figures do not believe its drive to overhaul regulations goes far enough. They argue that the EU executive is dancing around some of the core issues. Drug firms point to market fragmentation, strict state price controls and the cross-border prescription trade as a drain on the resources industry needs to be at the cutting edge of innovation.
Tom McKillop, president of industry umbrella group EFPIA, says: “A key factor in undermining European pharmaceutical competitiveness is parallel trade in medicines between EU countries.”
Despite its limited scope on speeding up and centralising drug approval procedures and harmonising data protection, the Commission's regulatory review is, nevertheless, viewed as a significant step forward by industry. “The industry is under enormous pressure to innovate or die,” says EFPIA director-general Brian Ager. “The proposed regulatory review is really important because it will set the pace for the European pharmaceuticals industry for the next 10 to 15 years.”
The milestone proposals have won the backing of the industry committee and the environment committee is expected to vote on them in October, once members have managed to sift through more than 700 amendments on the table. Nevertheless, as the sheer volume of amendments suggests, MEPs have serious misgivings about the project. These, in part, reflect civil society concerns, as well as the reservations of different industry players.
Regulatory data protection (RDP) has proven to be among the most contentious issues. Whereas a patent protects the chemical structure of a molecule, RDP shields research work, clinical trials and regulatory documents. Drug firms already enjoy 20-year patents across the EU, and the Commission is now proposing to offer a 10-year protection for RDP, plus an extra year for any significant new use for the drug the firm might discover.
Industry has welcomed these proposals because, companies say, at stake is the amount of time generic rivals will have to wait before they can gain access to these crucial documents, which take years of costly research to produce. They also argue that with spiralling R&D time and complex approval procedures consuming so much of a molecule's patent life, RDP can sometimes be their main incentive for innovation.
“We want to strike a balance between the innovative industry and the generic industry,” says Dutch Socialist MEP Dorette Corbey, who sits on the environment committee. “We should give the innovative industry protection, but they can't complain. They have enough protection as is indicated by their high profit margins.”
“Data protection should be reduced, not increased, in the interests of public health,” Corbey adds.
Humanitarian organisations also back the reduction of data protection because of its knock-on effect on price in developing countries. “Harmonising data protection upwards is equivalent to extending monopolistic conditions, and that is a major cause for concern to global prices,” says Ellen t' Hoen, globalisation coordinator for international humanitarian NGO Médecins sans Frontières.
The environment committee has proposed taking one to four years off the RDP shelf-life proposed by the Commission. It has also suggested that data protection and patents should be linked so that they expire simultaneously.
“These amendments suggest a complex and inappropriate link between the two forms of protection, and could nullify the benefit of regulatory data protection in some cases,” EFPIA said in a recent communiqué. The industry also argues that generic manufacturers have already been given their cut of the action in the form of proposals to allow them to start preparing their products for market some two years before the patent holder's exclusive rights expire.
One area where the views of industry and MEPs appear to converge is on the issue of how much national control to cede to the EU.
There are currently two drug approval systems running in parallel: the central system at EU level, via the European Agency for the Evaluation of Medicinal Products (EMEA), and each member state's national authorities, which operate a number of so-called ‘mutual recognition' systems. While the Commission stresses that the two systems should continue to operate in tandem, it favours a gradual migration towards centralised approval.
“We have doubts about this because the European market will lose the flexibility it has now,” says EFPIA's Ager, noting that for major releases drug giants will favour the more expensive central procedure. He pointed out, however, that there were drugs with appeal only for some EU markets and mid-sized firms could not afford registering with the EMEA.
Corbey agrees “there should be a balanced mix between national and central approval systems to ensure that expertise is maintained on a national level”.
For various reasons, the environment committee and industry have their reservations about the freedom of information, or advertising provisions, in the Commission's proposals.
To overcome the dearth of prescription drug information available to European patients, the Commission is proposing a pilot project where companies will be allowed to ‘advertise' directly to patients about drugs for three test disease areas. They will only be allowed to provide ‘factual' information about the diseases. Some MEPs are concerned that liberalisation of the rules governing the advertising of prescription drugs could lead to abuses by drug firms looking to up their sales.
“The problem the Parliament has is there is no clear divide between what constitutes information and what constitutes advertising,” Corbey argues. “This might eventually open the door to in-your-face advertising, like in the US. Everyone agrees that that patients should have information, but this information should be independent and objective.”
In contrast, drug makers argue that liberating information regulations will be healthy for patients wanting to learn about the medications available for their diseases and will aid them in making informed decisions with their doctor. “Everyone can publish information on a drug except the drug company who have scientists that have been intimately involved with it for 10 years,” Ager says. “Drug companies are the least likely to mislead patients because they need to protect their brand image.”
Ager criticises the Commission's proposals on information for being half-hearted and calls for a more radical shake up. He says that, under a strict system of self-policing and supervision from EMEA, the industry should be allowed to share its knowledge openly with patients.
This article first appeared in the 25-31 July 2002 edition of The European Voice.