Rada opens access to results of clinical trials of medicines
Ukraine's Verkhovna Rada has passed at second reading bill No. 4074 about the opening of access to the results of preclinical study and clinical trials of medicines.
A total of 247 lawmakers backed the document on Tuesday.
"The bill is aimed at harmonizing the provisions of national legislation with the relevant provisions of the EU Directive 2001/83 on ensuring public access to the results of preclinical study and clinical trials of medicines," Head of the parliamentary health committee Olha Bohomolets said during the presentation of the document in parliament.
She drew attention to the fact that, in accordance with Article 14 of the law on information, data about the effect of the product on life and health of a person cannot refer to information with limited access. At the same time, the current version of the law on medicines says that all information contained in the registration dossier is closed, which does not comply with European requirements and does not ensure the right of citizens to access information that is of public importance and interest.
According to the document adopted on Tuesday, the Ministry of Health of Ukraine within six months from the date of publication of the law should develop the regulatory and legal acts required for the implementation of the changes.
As reported, bill No. 4074 was voted at first reading by the parliament on November 2, 2016. At the same time, a number of sectoral associations opposed this document. Thus, the European Business Association stated that the conditions for accessing clinical trial materials laid down in the bill could carry risks for pharmaceutical companies, and the bill itself leaves room for manipulation of data on clinical trials.