An original medicinal product should be preceded over various steps before taking an authorization from the competent authorities. In order to achieve this, security and the efficiency of the medicinal product should be tested and several clinical tests should be applied1. These trials, being subject to various criteria and phases, are conducted on volunteers if the results of in-vitro and animal trials (pre-clinical test) are found satisfactory. Trails, depending on the nature of the related research, should either have a scientific objective or made particularly for treatment purposes only and may be divided into phases, being as the prior or after the authorization.
Clinical trials are not just limited to drug-specific researches and explore non-drug type of researches as well. According to the definition provided in the legislation, these are the researches on human beings, with non-industrial advanced medicinal products, non-medicinal standard treatment applications and genetic materials and further include stem cell transplantation, organ and tissue transplantation, medical products and trials for purpose of treatment. Observational studies on medicinal products are regarded out of the scope of the clinical trials and evaluated under a separate legal regulation.
Primary regulations in Turkish law regarding the clinical trials are the provisions of the Constitution on body immunity and Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, which Turkey is a party. Article 90 of the Turkish Criminal Code which stipulates the eligibility requirements of the experiments on human; Regulation on Clinical Trials; Article 13 of the Regulation on Medical Devices; Regulation on Patient Rights and Regulation on Medical Deontology are the other related substantive legislation. Helsinki Declaration of the World Medical Association and EU Directives 2001/20/EC and 2005/28EC are the piece of legislation that is considered as a reference for Turkish law.
Regulation on Clinical Trials2 has the substantive provisions regarding the clinical trials in Turkey among the above-mentioned regulations. Regulation was prepared by the Ministry of Health by taking into consideration the EU Directives. Recently, Turkish Medical Association (TMA) has filed a lawsuit against the Ministry of Health before the Council of State and requested the cancellation and stay of execution of the certain provisions of the Regulation based on the allegation that it contains provisions against the Constitution, Helsinki Declaration and the EU directives.
Motion for stay of execution has been partly granted by the relevant chamber of the Council of State and TMA has appealed this interim decision before the Board of Chambers of the Council of State (BCCS). BCCS has primarily reviewed the procedural aspects of the Regulation without going into the merits and ruled that the provisions regarding the human body immunity which is protected by the Constitution should be regulated by a statute to be enacted by the Parliament and should not be set forth with a regulation which is an administrative act of the Ministry of Health and therefore granted the motion for stay of execution on the regulation provisions as requested by the TMA.
A question mark has occurred on the status of continuing trials and the ones to be conducted in the future due to the stay of execution decision. A judgment, canceling the regulatory action has an automatic outcome, which means that the administration cannot take any action based on that cancelled regulation and otherwise the administrative action would become null. However, an evaluation needs to be made on a case by case basis, whether any vested rights have arisen with the administrative action before the cancellation of the regulation and whether the cancellation and thereafter the implementation in due course has diminished the administrative stability.
Effect of the decision would occur automatically when a stay of execution decision is rendered, same as being for the cancellation of the regulation. Administration would have fulfilled the requirements of stay of execution decision by suspending and not taking any further steps on the pending actions. In that case, what would happen to the status of individual actions instituted in accordance with the regulation before it was cancelled? The rule is that if any vested rights have arisen with that individual action, it would continue to have legal effect. A case by case analysis should be made depending on the nature of each event.
Non-application of the stay of execution could be the case if the implementation of that decision is legally and de facto impossible3. If we make an analysis regarding the stay of execution decision on clinical trials by applying the above mentioned legal principles, it may be argued that there is legal and de facto impossibility in applying the stay of execution decision for the trials that have taken previously permission from the Ethics Board and the Ministry of Health.
However, instead of making a generalization here, it would be wise to give a decision for each specific clinical trial by taking into account the issues such as the nature of clinical trial, the effects of the suspension that it would cause on volunteers in terms of health and in which phase the clinical trial is conducted. Ultimately, it is expected that this legal gap would be temporary and the legislator by virtue of the importance of the subject, would enact the relevant statute soon. It should also be noted that even if the legislator enacts a statute on the subject, concerned parties may still challenge the provisions on clinical trials and may carry the matter to the Constitutional Court and therefore, if a statute is to be prepared, to which extent it would be in parallel to the above mentioned legislation would be vital.
On the other hand, it is noted that the European Commission has a tendency to change the existing directive, taking into consideration the needs of the sector, but it is expressed that such a change is not expected before the end of 2011.
1. This article reflects the legal situation as of the date it is published.
2. Numbered 27089 and published at Offical Gazzette on 23 December 2008.
3. Council of State, 13th Chamber, 29.11.2005 dated.,E:2005/5546, K:2005/5699.
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