round table discussion on “Legal support clinical research and postklinicheskih medicines in the context of patients’ rights.”
Relevance activities due novels legislation, which came into force throughout the year.
Since the Law of Ukraine on May 12, 2011 N 3323-VI has made changes to some legislative acts of Ukraine regarding clinical trials, which could not affect the procedure for conducting such tests inUkraine.
The event was considered by a number of pressing questions about the proper conduct of clinical trials of medicines in the light of patients’ rights in accordance with the requirements of Ukrainian legislation and international standards. Responses to question the participants were given the leading specialists – practitioners of the Committee on Medical Law and the Committee on pharmaceutical law AAP representatives Ukrainian Council of protecting the rights and safety of patients and professionals who are directly involved in conducting clinical trials on medicinal products in Ukraine.
The round table was opened by the report manager for clinical trials of NBScience limited (GB), k.med.n., Eugene Zadorin. Mr. E. Zadorin thoroughly highlighted the issue of clinical trials of drugs given the demands of world and national standards, in particular GCP – Good Clinical Practice. Noted international standard defines the ethical and scientific quality standards for the planning and conduct of clinical trials of drugs in humans, as well as documenting and presenting their results.
It was noted that compliance with the standards mentioned Ukrainian researchers will create a positive image of our country, which in turn will increase the number of clinical trials in Ukraine.
Mr. E. Zadorin spoke about the global practice of database of planned and ongoing studies, such as base Boaz – International Clinical Trials Registry Platform – Search Portal; base in theU.S.- ClinicalTrials.gov. With information such bases can get to know the citizens of any country intending to participate in clinical trials of drugs that will be held in their country. Similar to the Ukrainian-base does not currently exist, so the domestic patients are limited in their right to participate in such studies.
Rapporteur also highlighted issues of control over the accuracy of clinical trials of medicines. In particular, the organization of US Food and Drug Administration (FDA) and European Medicines Agency (EMEA) conduct periodic inspections of the conduct of clinical trials in Ukraine.
The issue of ensuring the rights of patients in research of medicines was discussed by Victor Serdyuk, president of the Ukrainian Council of protecting the rights and safety of patients. Mr. V. Serdyuk said that in recent years has sharply reduced the number of studies of drugs conducted inUkraine. This fact negatively affects primarily for patients, as well as on the economy of our country.
Negative consequences for patients due to limited capabilities of patients who need to provide expensive drugs (such as the treatment of cancer), to take part in the study of new drugs, which are provided free of charge to such patients. In addition, Victor G. drew attention to the fact that patients who participate in clinical trials, the sponsor pays the researcher as a basic treatment they receive. Financial support from the pharmaceutical company helps seriously ill citizens ofUkraineto be secured all the necessary medicines for the duration of the study. And this fact is very important, given the small public spending in the health sector, in particular, to receive free or reduced price drugs.
Mr. Valery Serdyukov also said that if the number of clinical trials of medicinesUkrainedoes not receive additional investment, which could come from customer research. The sizes of investments are not one hundred thousand dollars.
Summing up his report, Victor G. said that faced with the need to change the image of the country to return to its attractiveness to sponsors and researchers, as well as in establishing an independent organization to monitor compliance with the requirements of domestic researchers of international and domestic standards in the industry.
Practical experience in legal support to patients in clinical trials of drugs shared the head of legal department of the All-Ukrainian Council of protecting the rights and safety of patients, Olga Skorina.
The second part of the roundtable disclose relevant information and contractual matters of the plane.
One important aspect of clinical trials of medicines is the correct binding contractual relationship. It is this aspect highlighted in her message, a lawyer, doctor, head of the Medico-Legal Portal “103-law.org.ua», head of the Committee on Medical Law Association of Lawyers of Ukraine Elena Bedenko-Zvaridchuk.
Given the central theme of the round table – to ensure patients’ rights – Mrs. E. Bedenko-Zvaridchuk paid more attention to two aspects:
– Insurance contracts in favor of the study,
– Providing information and obtaining consent from study to participate in clinical trials.
In response to questions from the participants, Ms. Helen noted that the current legislation prohibited mark in insurance contracts as an exception to insurance claims of non-professional health workers, delayed excretion of the patient from the study did not address factors that may lead to an insured event and the like.
One issue that caused heated debate in the audience, was to provide information to the patient and obtain his consent to participate in clinical trials of medicines. Rapporteur gave examples from his own medical experience regarding the difficulties in informing patients about treatment and diagnostic process. It was also noted that given the financial appeal for terminally ill patients to take part in a clinical trial, are non-trivial cases of fraud anamnestic data. Thoughtlessness of the behavior of the patient may increase the frequency of adverse events in the application of a new drug that affects the patient’s body. In addition, these facts can be regarded as a side effect of the medicinal product, which in turn results in inaccurate results.
Participants also considered the question of treaties concluded between legal entities (Sponsor – CRO – medical institution / researcher). It was noted that quite often such contractual relationships are opaque. This negative point arises because of some restrictions on the receipt of additional funds medical institutions, financed from the state budget. However, sponsors of clinical trials, customers (the leading foreign companies) are interested in transparency in the use of funds provided for research. Probably, this fact also undermines the image ofUkrainein the world and reduce the number of people willing to includeUkrainein the list of countries that will participate in a multicenter clinical trial.
The presentation (PowerPoint)
Particularly provoked a lively discussion topics of the last report – Protection of personal data of patients in clinical research – presented an adviser on medical issues of the South Caucasus” Legal Alliance” Leonid Shilovsky.
Mr. L. Shilovskiy talked about novels of domestic legislation concerning the protection of personal data of persons involved in clinical trials of drugs, and analyzed the European Court of Human Rights on this issue. The outcome of this debate was the initiative of participants to request the State Committee for Protection of personal data. The text of the request and the response to this request (after receipt) will be available on the website of the Association of Lawyers of Ukraine.
According to the results of the event is made official document to send to the state authorities – Resolution Round Table “Legal support clinical research and postklinicheskih medicines in the context of patients’ rights.” The text of the Resolution is available at the Ukrainian Bar Association.
Summing up the round table should be noted that the participants had the opportunity to ask experts questions and get qualified answers to them. Note that this event is not limited attention to the problematic issues related to clinical trials inUkraine. At the request of the debate in this year’s event will be held unscheduled Committee on Medical Law AAP, which will reveal the current issues of clinical trials involving children.
The initiator of the round table was the Committee on Medical Law, with the support of the Committee on pharmaceutical law AAP, the company NBScience limited (GB), the Association of Medical Education of Ukraine, the Ukrainian Council of protecting the rights and safety of patients and medical-legal portal “103-law.org.ua» .
To participate were invited to the Ministry of Health, NGOs, embassies, and practicing lawyers, doctors, researchers, managers and representatives of the CRO.
The event organizers wish to thank the head of the Publishing House “Zaslavsky” – Mr. Alexander Zaslavsky – for long-term information support of the Committee on Medical Law and APU for the opportunity to hold a round table in the shop area of medical books “Bukvamed.”
Media partner of the Committee for Medicinal and pharmaceutical law AAP is MEDPHARMCONNECT – Information Portal for doctors and pharmacists