Ukraine parliament launches historic revision of pharmaceutical legislation

Ukraine

On 9 September 2021, the Ukrainian parliament supported in the first reading a revision of its legislation on medicines, initiating a two-week period for submitting amendments to the basic version. Several months from now, after extensive parliamentary work on the second version, Ukraine's parliament is expected to proceed with the second reading and ultimately replace the nation's out-dated 1996 Law on Medicines.

The New Draft Law now enjoys a priority position in the political agenda:

  • On 18 August 2021, the Ukrainian President approved the Decision of the National Security and Defence Council (NSDC) on healthcare, which has prioritised the New Draft Law as a move to align domestic legislation in the pharma sector with EU legislation.
  • Moreover, the key sponsors of the New Law have presented it as a tool to start negotiations with the EU on the Agreement on Conformity Assessment and Acceptance of Industrial Products (ACAA) for medicinal products and free trade in this sector. The NSDC Decision defines negotiations with the EU over the ACAA as a key healthcare priority for Ukraine.

Experts are now debating whether the first version of the New Law is a move in the right direction or a mistake. It is too early to make predictions on the final version of New Law and the result of the second reading.

We see, however, strong progress in many directions and many potential threats and challenges for market players and the pharmaceutical regulatory system. Overall, we still believe that an open and professional dialogue and further updating of the draft New Law could bring EU-like pharmaceutical legislation to Ukraine. Otherwise, the legislation may end up a redecoration of the current regulatory framework with complications for businesses, risks for patients, and still no chance to discuss the ACAA and sectoral free trade with the EU.

Positive expectations

The following are the positive and constructive points contained in the draft:

  • Alignment with Directive 2001/83/EC
  • Improved procedure of marketing authorisation
  • Web-portal
  • Compassionate use
  • Promotion (other than advertising)
  • Falsified medicines

Possible threats and challenges

  • Definitions
  • New single regulatory body
  • Local MAH requirement
  • Data protection and exclusivity
  • Unclear transition

For more information on this draft legislation and opportunities in Ukraine's pharmaceutical industry, contact your CMS client partner or local CMS expert: Borys Danevych