Europe backs more transparent, simpler clinical trial rules
April 2 Wed Apr 2, 2014 2:18pm EDT

(Reuters) – European Union lawmakers voted on Wednesday in favour of new rules that will ensure more open reporting of clinical trials results, even when they are negative, and also simplify the process for getting studies started.

The legislation approved by the European Parliament is expected to take effect in 2016 and will require results of all new clinical trials to be published within a year of the trial ending.

European Ombudsman Emily O’Reilly, whose office investigates complaints about maladministration in EU institutions, said the move was “a triumph for transparency” in European healthcare.

There has been a growing clamour for greater disclosure of detailed clinical trial results by pharmaceutical companies following a series of scandals over the safety of drugs such as Merck & Co’s now withdrawn painkiller Vioxx.

A number of senior doctors have argued that in too many cases the decision on how and when to prescribe drugs relies on selective evidence controlled by manufacturers.

The new rules mean it will in future be possible for independent researchers to verify whether medicines are as safe and effective as they are claimed to be.

Ben Goldacre, a British doctor and author of “Bad Pharma”, who has led a campaign called AllTrials urging study disclosure, welcomed the vote by parliamentarians as “an excellent small step forward”.

But he remains concerned that the new EU Clinical Trials Regulation only covers new clinical trials and does not address access to full study results carried out on older medicines already on the market.

In addition to forcing greater transparency, the new law will also reduce the red tape surrounding the approval process for studies on medicines, including simplifying rules for running multinational trials.

Taken together, the measures should save research institutions and companies conducting clinical trials in the EU some 800 million euros ($1.10 billion) a year in regulatory costs, EU Health Commissioner Tonio Borg said in a statement.

($1 = 0.7263 Euros) (Reporting by Ben Hirschler, editing by David Evans)
Over a dozen Ombudsman inquiries about the Medicines Agency

Activists will recollect that phramaceutical MNCs have steadfastly opposed the idea of disclosing clinical trial data under the Indian RTI Act. They claim that this information attracts the protection of Section 8(1)(d) of the RTI Act which exempts disclosure of information that is in the nature of commercial confidence or trade secret or intellectual property if such disclosure will harm their competitive position. I remember assisting an NGO SAMA to access clinical trial data about HPV vaccine under the RTI Act a few years ago when the DGHS refused to part with this information. Subsequently political parties took up the issue in Parliament. I have not followed up on this case since then. Perhaps readers may educate us in the regard about the latest developments in INdia.

Many companies in the pharma sector and their advocates in the legal fraternity in India have treated this category of information as confidential. They argue that disclosure will adversely affect their ability to innovate and provide effective medicines at competitive rates. Their main concern is about access of such kind of data by companies that manufacture generic equivalents of such drugs and supply them at cheaper rates to developing countries that cannot afford to buy their astronomically priced medicines.

The RTI jurisprudence on this issue is not well developed in India. I could find only a handful of cases on the website of the Central Information Commission (CIC). In 2011 the CIC accepted the arguments of the pharma MNCs that clinical trial data contains information in the nature of intellectual property and may not be disclosed (1st attachment). However in 2012 the CIC ordered disclosure of clinical trial data in another case (2nd attachment). The Supreme Court has been moved in a similar matter through a public interest litigation suit though not under the RTI Act. See news story at: I have not been able to find out if this case has been decided at all now.

The new law in the European Union should make the multi-national pharma companies reconsider their arguments to prevent disclosure of clinical trial data to the public. However as most major pharma MNCs have their base in the USA it would be interesting to watch their reaction to this new law. The European law requires even negative results of clinical trials to be made public. Come to think of it, do not pharma MNCs have a fiduciary duty of disclosure of the truth to the people in general and medical practitioners in particular? I hope Information Commission in India take note of this change in law in the European Union and deal with appeals relating to access to clinical trial data with greater alacrity even to the extent of erring on the side of transaprency.