1 December 2013
Begun in 1996, the conduct of international clinical trials in Ukraine has seen an explosive growth. It has to be said that this country is attractive to pharmas: located at the edge of the European Union, its population is mainly urban and genetically close to that of “western” populations. The economic situation is difficult, and the state healthcare system is not in good shape. The patients, made fearful by an alienating historical heritage, are easy to recruit. Lastly, running a test in Ukraine costs only up to half as much as in western Europe. Between 2001 and 2009, the number of sites authorised to run clinical trials has exploded, going from 175 to more than 1300, according to official figures.
This increase in clinical trials has been accompanied by numerous ethical violations, encouraged by a fragile legislative framework. While Ukraine recently integrated international standards in its legislation, these reforms have not yet been assimilated by all the key players, and in particular the doctors and ethical commissions. Previously managed in a centralised way, the authorisation procedure for trials has, since mid-2012, been presented for approval to local ethical committees. However, because of a lack of resources and a clear framework, these structures are far from being operational everywhere in the country. Being attached to the institution responsible for clinical trials, these ethical committees suffer from a lack of independence. In addition, the central committee of the Health Ministry, which has not been active since April 2012, has left a worrying vacuum in terms of ethical control.
The total absence of public debate on this subject is also problematic. For the patients, clinical trials represent a unique opportunity to get access to quality care that they could never normally afford. In certain, particularly scandalous cases, doctors even present the situation to patients in terms of a “humanitarian programme distributing free treatment,” without specifying that it is a clinical trial. Others openly minimise the regulations applying to informed consent, stating that a member of the family could very well sign the form on the patient’s behalf. As the legislation indeed tolerates signature by a “witness” in certain cases, employees in several hospitals have even signed the forms themselves.
Orphans as guinea-pigs?
In March 2013, Ukrainian members of parliament denounced the illegal practices of several pharmaceuticals companies in their country. The example they cited concerned three clinical trials conducted between 2011 and 2012 on children, some of them orphans, which in particular violated the consent procedure. Among these tests was the trial conducted by the Swiss firm Actelion on their product Tracleer (bosentan), a treatment for pulmonary hypertension. The involvement of children requires the consent of both parents or – if he or she is an orphan – a representative of the state. The members of parliament assert that this rule has been broken in several cases. Moreover, the trials took place at sites that did not have the required authorisations. The Ukrainian government formally denied the accusations, while the pharmaceuticals companies for their part have remained silent on the subject.
This investigation has not (and probably will not) be followed up or updated. The results published on this web site are those obtained during our research in 2013.