Clinical Trials of Medicinal Products in the Draft Law of Ukraine “On Medicinal Products”
For less than six months of work on the draft law we can speak about seven meetings of the working groups that have already been held with the participation of the representatives of the Ministry of Health of Ukraine, professional associations, practitioners in the field of medicine and pharmacy, lawyers, etc. As the result of the meetings of the working groups the structure of the new law was agreed upon and its foundation was developed.
The difficult task in the work on a draft law, which has already been managed to a greater extent, is the availability of different views on the key issues held by the market regulators and professional associations.
The result of a joint work of representatives of the State Expert Center, European Business Association, health care professionals and other members of the industry has become a section on the development of medicines. It is based on the 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.
The section on the development of medicinal products consists of the five following Articles: Stages of Development of Medicinal Products, Pharmaceutical Development of Medicinal Products, Pre-clinical Tests of Medicinal Products, Clinical Trials (Studies) of Medicinal Products, Protection of Patients (Healthy Volunteers) who are Involved in the Clinical Trials (Studies) on Medicinal Products.
Novelty of the draft is an article on the pharmaceutical development of medicinal products, introducing definition of non-interventional studies of investigational medicinal product to the level of law. It is also proposed to set out in the draft law that the development of medicinal products is an activity of legal entities and natural persons intended to create new medicinal products and consists of the following stages: a pharmaceutical development; pre-clinical tests; clinical trials (studies).
As previously, the favourable opinion on conducting clinical trials, except for non-interventional trials, approved by the Ministry of Health of Ukraine and the approval of ethics committee established and operated under the healthcare facility where the clinical trial on medicinal products is planned to be undertaken are needed to start clinical trials (studies) of medicinal products.
Furthermore, the mandatory character of the Good Clinical Practice and the Good Manufacturing Practice for conducting the clinical trials (studies) of medicinal products is remained. The pre-clinical tests of medicinal products shall be also conducted in compliance with requirements of Good Laboratory Practice. It is proposed to oblige laboratories which conduct pre-clinical tests to undergo mandatory certification of compliance with Good Laboratory Practice since April 1, 2017.
However, unlike it is in the current legislation, we offer to oblige the sponsor of the clinical trials (studies) or his/her authorized representative to conclude a contract for liability insurance of the sponsor of clinical trials (studies) prior to the commencement of the clinical trials (studies) to cover damage occurred to life and health of subjects. Respective changes we propose to make in the Article 7 of the Law of Ukraine “On Insurance”. Please note that as of today a life and health insurance contract is needed to undertake clinical trials (studies).
More details will be set out in the new section of the draft law, named procedure for conducting clinical trials (studies) and examination of their materials.
Thus, Ministry of Health of Ukraine should implement new provisions and develop the following procedures: the procedure for import into the customs territory of Ukraine, recording, storage, use, destruction, disposal or export from the customs territory of Ukraine of investigational medicinal products, the order procedure for keeping the State register of clinical trials (studies) on medicinal products.
Separate Article is devoted to the protection of patients (healthy volunteers) who are involved in the clinical trials (studies) of medicinal products.
the possibility to give informed oral consent in the presence of at least one witness, if the patient (healthy volunteer) or his/her legal representative is unable to provide it in the written form, is adopted directly from the Directive 2001/20/EC. Thus, a requirement of the presence of at least one impartial witness was replaced by the more stringent demand of the presence of at least two impartial witnesses, which seems to be more suitable for our conditions.
Especial protection of clinical trials (studies) subjects is also set out with an intention to comply with European law. For example, the clinical trials (studies) of medicinal products involving minors or underage persons may be undertaken only if the concerned medicinal product is intended exclusively for the treatment of childhood diseases or if clinical trials (studies) are designed to optimize the dosage or mode of administration of the medicinal product for the minors or underage persons respectively. The clinical trials (studies) of medicinal products involving minors or underage persons and designed to optimize the dosage or mode of administration of the medicinal product for such persons are conducted after completion of clinical trials (studies) of the medicinal products involving adult capable persons.
However, unlike in the European legislation in the draft law we tend to ensure more protection for socially vulnerable individuals and therefore set out that it is prohibited to conduct clinical trials (studies) of medicinal products involving minors or underage persons deprived of parental care, adopted or orphan children.
Furthermore, like in the Directive 2001/20/EC the patient (healthy volunteer) or his / her legal representative is entitled to refuse to be involved in the clinical trial (study) at any time of its conduct.
Obviously, an important step towards the harmonization of Ukrainian legislation with the EU acquits, in particular in the work on the draft law on medicinal products, will be collaboration with the World Health Organization and the European Commission. We have already received confirmation on the possibility of providing technical assistance from the Ukrainian office of the World Health Organization. It is planned that the work on the English version of the document will be held by experts from the Baltic countries, which have valuable experience of the transition from the former Soviet legislation to the EU legislation.
Khrystyna Demchenko , Junior associate with Legal Alliance Company
Nataliia Modlenko, Associate with Legal Alliance Company
The Legal Alliance Company proceeds with its work on the Draft Law of Ukraine “On Medicinal Products” in the team of following dedicated specialists: partner with the Legal Alliance Company Mr. Dmytro Aleshko as well as associates Mr. Alexander Yanev and Mrs. Natalia Modlenko.