The Other Side of Transparency


Applied Clinical Trials

Amid all the heated discussions of transparency and the insistence on ever wider disclosure, an intriguing contrast is provided by a document signed by health ministers on June 20.

Amid all the heated discussions of transparency and the insistence on ever wider disclosure, an intriguing contrast is provided by a document signed by health ministers on June 20. The document is a small revolution in itself—an innovative mechanism designed to change the relationship between governments and medicine manufacturers, in what the European health commissioner Tonio Borg described as "an epic event." It is a joint purchase agreement setting out how EU countries can conduct joint procurement of pandemic vaccines and other medical countermeasures. Borg says it will help guarantee supplies and "will militate against price speculation in medicines."

The initiative is the EU's response to past embarrassments, when countries seeking to obtain vaccines and other medicines during the H1N1 pandemic found themselves vying with one another for supplies, and—as they felt—at the mercy of drug firms benefiting unduly from the situation. The mechanism is described by the EU as "a key achievement to better protect citizens from serious cross border threats to health. Joint procurement enables member states to ensure that pandemic vaccines and medicines are available in sufficient quantities and at a correct price should a cross-border health threat emerge." It says the mechanism "will benefit all EU countries, in particular the ones which encountered difficulties in purchasing vaccines developed for the H1N1 pandemic in 2009." Member states can "join forces and purchase together vaccines and other medical countermeasures," and "secure vaccines and other medicines for their populations under better conditions than in the past." Already a meeting of a new working group is scheduled on July 3-4, and the European Commission is encouraging health ministers to rapidly nominate their representatives for a new steering committee, which will hold its first meeting in September.

The document that ministers have signed binds them to certain procedures when they put together joint procurement exercises. Among those are some routine declarations by participating officials that will have to state that they have no conflict of interest with any of the companies that respond to calls for tender. But officials will have to go further. The model declaration they will have to make goes on: "I also confirm that I will keep all matters entrusted to me confidential. I will not communicate outside the committee any confidential information that is revealed to me or that I have discovered or any information relating to the views expressed during the evaluation."

Now here we have a pretty big agenda for the officials who are going to work on this committee and make these new deals with the industry. The underlying EU legislation says they are "to adopt common approaches to the negotiation of contracts with the industry, that would clearly address issues such as liability, availability and the price of medicinal products." It is all the more "epic," to use Borg's vocabulary, because Borg went on to suggest, after the signing ceremony, that this type of deal could also serve as a model for further types of agreements to get a grip on drug pricing more broadly.

Yet while industry is expected—nay, obliged—to maintain high levels of transparency over each of its cinical trials, and is now casting before the public all its details of sponsorship of a square meal or every night it provides in a hotel to any healthcare professional, is it not just a little inconsistent that the workings of this new and powerful committee should be subject to the most hermetic rules about what goes on there or what any of its members are allowed to say. While the delicacy of negotiations often does require a certain degree of discretion, here, on a matter of some moment, it seems there is just a hint of different rules for different organisations. Which leaves open the age-old question, if this committee is the new custodies, of quis custodiet ipsos custodies?

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