Bureaucratic burden and uncertainties caused by lack of sufficient and relevant regulation were blamed by the pharmaceutical industry as one of the significant reasons for the relatively low number of clinical trials conducted in Turkey despite its potential in terms of population, qualified personnel and geographical location.
The amount of investment in clinical trials in Turkey is expected to significantly rise in the near future due to willingness of the government as well as pharmaceutical companies for more investment in that area. Despite uncertainties the number of clinical trials conducted by innovative pharmaceutical companies is reported to have risen by 30 to 40 percent in 2008.
A new regulation, the Regulation on Clinical Trials1 (the Regulation) was published in December 2008 and entered into force in January 2009 with the intention to bring the legislation in line with the relevant EU legislation in consideration of the EU Directive 2001/20/EC of 04 April 20012 and the EU Directive 2005/28/EC on (GCPG) Clinical Trials3. The Good Clinical Practice Guideline was renewed in the beginning of 2009.
This article intends to give a general overview in relation to third party liability insurance requirements covering a clinical trial in Turkey.
Article 31 of the Regulation provides that all legal and financial liabilities arising from a clinical trial rest with the persons, institutions/corporations conducting the clinical trial, the sponsor and the contractual research organizations.
According to general provisions of Turkish law, possible claims of a person whose health has deteriorated as a result of the clinical trial may include expenses for treatment and care, damages arising from permanent or temporary loss of occupation, and damages for immaterial suffering. In the event of a death, possible claims of legal heirs may include expenses for treatment and care prior to death, funeral expenses, loss of financial support of the deceased and damages for immaterial suffering.
The Regulation Article 11 on Authorities and Responsibilities of the Ethics Committees provides under section 5, that Ethics Committees in evaluating a clinical trial application in Turkey shall consider as one the criteria the extent of the insurance policies in relation to liability of the sponsor or the researcher and the cover of policies issued for the benefit of the volunteers for any likely occurrence of death, injury or permanent health problems. (Phase IV trials are not within the requirement for insurance).
Article 19 of the Regulation on the Initiation of a Clinical Trial provides that a clinical trial can only be commenced upon approval of the General Management of Medicine and Pharmacies of the Ministry of Health further to the approval of the Ethics Committee. The relevant General Management would consider the adequacy of measures for compensation of losses to be incurred in case of death of or damage to the volunteers and of the extent of cover of the insurance policy regarding liabilities of the sponsor.
Is a separate policy for Turkey to cover clinical trials necessary? Is a foreign insurer acceptable under Turkish law to issue the cover?
Especially where a multi – centered clinical trial is conducted including Turkey as one of the sites and an insurance policy is issued by a foreign insurer, questions used to arise in the past in relation to the admissibility of the policy in getting approval for the relevant clinical trial.
The Act on Insurance No. 5684 Article 15 provides that Turkish legal persons must have their insurable interests in Turkey insured by Turkish insurance companies. Article 15 (2) of the Act further specifies which insurance policies can be obtained from abroad and did not include clinical trial third party liability policies.
The Treasury published a decision on 11/01/2008 stating that "third party liability insurance required by the Ministry of Health in relation to clinical trials have been added to the types of policies which can be obtained from abroad".
An insurance policy issued by a foreign insurance company would therefore be admissible to obtain approval for a clinical trial and there is no requirement for a separate local policy for Turkey. A global policy topped up in line with the specific requirements in relation to clinical trial insurance policies cited below would in principle be admissible.
What needs to be included in the Insurance Policy?
There is no specific provision in the Regulation or the GCPG in relation to the required extent of cover of the clinical trial liability policy for admissibility by the Ethics Committees or the General Management of Pharmaceuticals and Pharmacies of the Ministry of Health.
The Guide on Insurance for the Volunteers in Clinical Trials published on 10 February 2009 lacks clear wording but seems to be also regulating third party liability insurance although its heading and its purpose statement may be understood to suggest otherwise.
The Guide provides that the following must be explicitly identified in a clinical insurance policy. Some of those provisions are based on the provisions of the Insurance Section of the Turkish Commercial Code.
- Name, surname, trade name and address of the insurance company and the insured, and the beneficiary if any. Subject of cover (including full name, protocol number and the content of the clinical trial)
- Covered risks (cover for treatment expenses, illness, disablement and death must be provided) and the date of commencement and termination of cover.
- Liability limit (per person and total)
- Premium amounts, due dates and place of payment
- Number of volunteers that will attend the clinical trial
- Policy period, (the policy term should be for at least between the dates of the commencement and termination dates of the clinical trial - no distinction made between occurrence based or claims made policies)
- Date of Issuance of the policy and original signature4
- Special conditions
- Any Additional cover
- Countries for which the policy provides cover
- If the insurance bears a foreign element, provisions in that regard5
- Amount of deductibles or the existence of co - insurance
- A copy of related general conditions certified by the Ministry of Commerce (relates to local Policies)
Insurance policies must be in Turkish if the policy is issued by a Turkish insurance company. Where the policy is issued by a foreign company in a foreign language, an original copy or a certified copy of the original policy along with a notarized translation must be submitted to the Ethics Committee.
There is no minimum policy limit foreseen in the relevant legislation or established standards in that respect. Varying policy limits have been admitted by Ethics Committees according to the circumstances.
Again there is no particular approach of Ethics Committees in relation to a possible exhaustion of indemnity limits due to cover of losses in other countries covered by a global policy and there is no regulation or a standard application in that respect.
Footnotes
1. Turkish Physicians Association ("Association") has filed an action on 23 February 2009 requesting the cancellation of some of the provisions of the Regulation on the grounds that they are not in conformity with the international agreements in which Turkey is bound by. The case is pending before the Council of State.
2. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.
3. Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.
4. Applicable to local policies
5. It is not clear what is meant by this provision. This may mean for example applicable law and jurisdiction where these are not Turkish law or jurisdiction.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
