Grasping Banality Firmly in Future Pharma Policy


Applied Clinical Trials

The European Union has managed to snatch defeat from the jaws of opportunity once more!

The European Union has managed to snatch defeat from the jaws of opportunity once more! A long-heralded document portentously entitled "Pharmaceutical industry: a strategic sector for the European economy," and supposedly initiating a new start in long-term thinking about boosting the drug industry, squeezes the thinnest and weakest of conclusions imaginable out of 25 pages rehearsing the challenges facing the sector.

It says: "Against this backdrop, Commission services will organize an event bringing together relevant EU and national public and private stakeholders: decision-makers from public bodies in charge of industrial competitiveness, health, pricing and reimbursement, research and innovation at Member States level, and their Commission counterparts, patients, healthcare professionals, trade unions and industry representatives. This event could provide an important contribution to an extensive debate on the European pharmaceutical industry."

An event! Something that "could" (it is not even certain that it "will") help. And not help the industry.  Just help a debate. And not even help it very much. Just might provide "an important contribution" to it. By the time the pharmaceutical industry actually gets a mention in the conclusions, the import of the sentence is so attenuated that it carries virtually no weight at all.

Observers of EU pharma policy have grown accustomed to pusillanimity. But this is a new level of timidity. What terror has seized the officials responsible for this shameful conclusion, and robbed them of the capacity to see how truly feeble their proposal is? "Against this backdrop"—to use their own terminology—of real issues, are they utterly unconscious of the utter banality of their response? Or are they conscious of it, but uncaring about it? Either way, it is a miserable attempt at strategic thinking, and another lamentable demonstration of the failings that bedevil EU policymaking.

The "backdrop" is depicted accurately enough.  "Europe’s pharmaceutical sector suffers from a lack of confidence, market uncertainty and budgetary problems which are currently preventing it from developing its full potential," says the document. It points to funding problems: "It is not only demographic change that is driving up healthcare costs, but also non-demographic determinants of care, such as medical innovations." So "revenues of the pharmaceutical industry will be subject to the utmost scrutiny." And "shortcomings in the coordination between the policy objectives and subsequent effects of national decisions in other member states can have detrimental effects by creating market distortions and endangering the predictability of the business environment for industry."  In addition, "the increasing focus on more complex diseases leads to increasing R&D costs." But with the emergence of rival health technology assessment methods across Europe, "diverging requirements between Member States can lead to shortcomings in the efficient allocation of resources, thus possibly to higher costs for competent authorities and industry and even to delays in access to new medicines for patients."

At the same time, "European companies are often faced with significantly lower levels of intellectual property protection in non-EU countries, particularly in emerging economies." And the list of obstacles goes on. "Access challenges occur along the value chain from discovery of a medicine to the use by the patient," says the document. For active ingredients, "the increased dependency on non-European sources has already led to concerns with regard to maintaining security and quality of supply in Europe."

The significance of the industry for Europe's economy, employment and innovation capacity is clearly outlined, alongside the looming threats in global competition. Unsurprising, the document states firmly that "It is therefore essential for the EU to maintain its competitive edge." But the document describes itself as "a first step in preparing a strategic agenda." A step like this is no step at all—or worse, a step in the wrong direction.

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