Embarking on a system change for clinical trials in 2013

In the last few years the pharmaceutical team at SOMO has placed the emphasis on research and lobbying to protect the rights of test subjects in clinical trials.

“In 2013 we will continue to be focused on this aspect of clinical trials, while also embarking on a system change within the clinical trial culture. The result we are aiming at is that clinical trials are only held for medicines which are actually needed, instead of for contested patent extensions and ‘me-too’s’ (products which largely duplicate the action of already existing drugs) which only serve the profit margins of the drug companies,” says SOMO researcher Irene Schipper.

SOMO is currently working on an article discussing the upcoming changes in European legislation and the possible dangers and lack of clarity these changes may bring. And that’s only part of what is planned for the next period.

European legislation on clinical trials is being revised at the moment. Nevertheless, it is unclear to many what the consequences and possible dangers of the current proposition are exactly.

“We have investigated this issue by talking to many different actors: the drug companies, the Dutch government (that will need to implement the new guideline), the EMA and ethics commissions. We are writing an article to present out findings,” says Irene Schipper.

The Indian Journal of Medical Ethics is publishing the article, written by SOMO and Wemos, in early 2013.

Changes in European clinical trial legislation

One of the changes in the European legislation is that there will be one single portal through which applications for clinical trials are to be submitted. The assessment of the application will be divided into two parts: a scientific assessment by one member state which will be binding for all member states; and an ethical assessment by the country where the trial is planned. It will be left to the individual member states to determine how to monitor compliance with ethical requirements.
Approval by an ethics commission will no longer be required and the ethical requirements of a clinical trial are also only briefly indicated.

Schipper: “And this while it is so important that international ethical guidelines are set as minimum conditions, to prevent the development of double standards.”

Other important changes concern the discontinuance of the obligatory insurance and indemnity (member states will be expected to install a national insurance mechanism instead) and introduction of co-sponsorship. The latter is a solution for the problem that an increasing number of separate networks are endeavouring to undertake clinical trials jointly, but cannot form a legal entity together, which is necessary for the currently obligatory ‘single sponsorship’. Allowing the absence of a legal entity in essence shifts the problem: if this is allowed, the patient who wants to sue for damages will have to find out who the actual legal responsible party is; a completely insurmountable obstacle for already vulnerable patients.

“The changes for European countries seem bigger than those for non-European countries, but one must not forget that clinical trials conducted in India, for example, must also meet European guidelines when they file a marketing application for the European market.”

Good practices ‘post trial treatments’

International guidelines state that every test subject has the right to be informed of the outcome of the study and the right to access to the tested medicine or a comparable treatment. This is especially of importance for test subjects in developing countries who would not have any access to the medication without this requirement. But what exactly can be expected from these companies or other sponsors? Does the right to follow-on treatment only extend to the test subject or also to their family members? And for what period of time? This is unclear, as are many issues surrounding post trial treatments.

“This is why SOMO, in collaboration with other organisations, is working on a position paper wherein we shall make various recommendations,” explains Schipper.

System change

In the past years, SOMO’s work was focused especially on the protection of test subjects. This will continue to be so in 2013. In addition, SOMO will also be following a second track. It would like to promote that there should be far more clinical trials carried out in the interest of the patients instead of in the interest of the drug companies’ profit margins. Pharmaceutical companies should be developing many more medicines for illnesses such as TBC and malaria and not only target the medicines which are most interesting financially. In 2013 SOMO is going to report on how many unnecessary clinical trials are actually being carried out.

Compensation

When test subjects have suffered injuries, or even death, during clinical trials, the financial compensation that they are entitled to has only actually been received in a very few instances. This proves to be the case in Europe too. How difficult is the process of gaining access to compensation? SOMO and partners will be looking into this in 2013.