On June 24, 2015 the public affairs office of the Ministry of Healthcare of Ukraine (the “MOH of Ukraine”) has announced plans to revive theOrder of the MHU №870 of October 9, 2013 that approved the Guideline “The medicines. Good Promotional Practice СТ-Н МОЗУ 42-1.2:2013”. If so, the Order of the MOH of Ukraine “On the Criteria Applied to Identifying Medicines Forbidden for Advertisement” № 422 of June 6, 2012 shall be amended as well.
It shall be mentioned that the Guideline has been elaborated to regulate promotion of medicines at the market, as long as the Law on Advertisement does not cover these practical issues, important for pharmaceutical companies.
The document has been developed in line with the provisions of Directive 2001/83/EC relating to medicinal products for human use and national industry-specific codes, in particular, EFPIA Code on the Promotion of Prescription-Only Medicines and IFPMA Code of Practice.
However, some Order’s provisions substantially differ from the ideas of current Law on Advertisement and Basic Laws of Ukraine on Healthcare. The Guideline shall regulate medicines promotion relations between pharmaceutical companies and medical professionals.
The Order has been cancelled on the demand of the Ministry of Justice as it violated legal requirements on registration of Ministry’s regulatory legal act. In particular, the Guideline contained imperative provisions effecting citizen’s rights and legally protected interests. Moreover, some of these provisions had interdepartmental character. Taking into account that Guideline should have been a document of technical and advisory nature, such provisions were subject to cancelation.
The Draft Law on Medicinal Products №2162 of February 17, 2015 and The Draft Law on Medicinal Products №2162-1 of March 2, 2015, registered by the Verkhovna Rada of Ukraine, have been also elaborated on the basis of Directive 2001/83/EC. These drafts regulate advertising and sampling issues as well as compete with the Guideline in many aspects. It would be interesting to consider their interaction in case of draft’s adoption
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