EU policy on pharmaceuticals is spot-on

Transparency regarding drug laws is important to enhance both credibility and verification.

Anant Naik

When new drugs and treatments that claim to solve specific diseases or illnesses are released into the market, we’re often reluctant to question the “science” behind these medications. After all, scientists must have conducted enough trials, right? Wrong.

Recently, the European Union sought to remedy this by passing an important regulatory law through the European Medicines Agency, or EMA, which is the EU’s body for the evaluation of medical products.

The EMA’s new policy allows other researchers to personally download clinical trial data.

Furthermore, companies often publish incomplete journal articles that disregard detailed data about clinical trials’ design, efficacy and safety. In fact, most studies they conduct aren’t published at all.

The EMA argued that its new policy will force companies to release this data for third-party analysis.

This is a great advancement for science and research as a whole. The transparency requirement is an achievement for the EU, and it should be brought to the United States as well.

First, the policy has an incredible capacity to improve public health. Under the EU’s old privacy laws (which resembled the current privacy laws in the U.S.), pharmaceutical companies in the EU reserved the right to keep the clinical trial data private. This meant that there were few opportunities for peer review and no public verification of any failures in the field. With the release of this data, qualified researchers are welcome to verify or critique the analysis of the data. This way, if a drug is released with controversial findings, we will be able to identify it more easily.

Second, I would argue that the new policy benefits pharmaceutical companies. For many years, pharmaceutical companies have been criticized for illegal operations and sales, overpriced drugs and a lack of transparency. Increased transparency could improve the standing of pharmaceutical companies by reducing these accusations.

Those who criticize the new policy generally say the policy could harm the commercial reputation of pharmaceutical companies and that it could harm patients’ privacy by releasing important data without their consent.

However, the first argument has little merit, especially because the first priority of pharmaceutical companies is to produce drugs that work. If they make drugs that don’t, they’re not doing their job. If anything, the policy helps the image of companies that have abided by regulations in the past. As for patients’ privacy, that’s a little more difficult, but not impossible, to overcome in the
future.

The U.S. should formalize policies similar to the EMA’s. With health care reforms recently receiving criticism, perhaps it’s time to shift the attention from hospitals and doctors to companies that provide the drugs. That would be a win-win situation for researchers and for the public, and it would be a prime example of how these two groups can work together.