March 13, 2013

The ownership of drugs data

Starting in 2014, clinical trials data of drugs approved by European agency will have to be released publicly. This has been a major claim by researchers and some regulators that are "concerned that too many drugs are approved based on selective evidence that exaggerates benefits and plays down the risks" as FT explains.
However, the news is that several companies are suing European Union to avoid such release of data, saying that this will harm their "competitive advantage". We are at a crucial moment. If these companies achieve what they want in the courts, it will be extremely difficult in the future to apply what it is expected for next January, the release of data to check safety and efficacy of drugs.
My understanding is that once you ask for authorisation you have to follow what the regulator has established, otherwise you should avoid such process and go to another market. Breaking the rules through the courts may be a successful strategy in corporate terms, but the firms can't forget that the final buyer and payer of pharmaceuticals is mostly the government, and it is the government who has considered that ownership of data is public once the drug is authorised. This is the cost of playing this game.