Tag: Ukraine

Ukraine introduces managed entry agreements for innovative pharmaceuticals

February 11, 2021

In January 2021, the Ukrainian Government introduced managed entry agreements (MEA), a market access instrument widely known in the European Union, but brand new to Ukraine. Managed entry agreements are arrangements between pharmaceutical companies and healthcare payors for innovative medicines that provide flexibility in managing the uncertainty around the financial impact or performance of such medicines. The introduction of MEAs in Ukraine should facilitate access to costly innovative health technologies which is needed in view of the budget constraints currently faced in the country.

Managed entry agreement regulations provide new business opportunities for innovative pharmaceutical companies in Ukraine.

Benefits of MEAs  

 Managed entry agreements provide flexibility for Ukrainian public payors when negotiating the terms of purchase for original medicinal products with pharmaceutical companies.  This flexibility provided by MEAs will better allow payors to manage the financial impact of such purchases.  Managed entry agreements may be: (1) purely financial agreements (e.g., agreements that provide discounts, supply of stock at zero cost at the initial stages of treatment etc.); (2) outcome-based (e.g., pay-for-performance); or (iii) a combination of (1) and (2).

The Ministry of Health (MOH) has stated that it intends to pilot MEAs on a more straightforward financial basis.  Most importantly, because MEAs will be deemed to be confidential, sensitive commercial terms (e.g., product pricing) will be protected from public disclosure. Only basic information on the product covered by MEA, its duration and parties will be released to the public.

Mandatory State Health Technology Assessment

The feasibility of a MEA for an original medicinal product must be confirmed by a state health technology assessment (HTA). A health technology assessment is a structured evaluation of the properties, effects and impacts of a health technology that is performed for the purpose of providing input on a health policy decision. State HTAs are intended to provide Ukrainian policymakers with data and evidence to support their decisions on how to efficiently direct limited health budget and select from a range of health technologies available.  The state HTA process may be initiated by the marketing authorization holder (MAH) at its own initiative or, under certain limited circumstances, at the request of the MOH. To participate in a state HTA, the MAH must submit a product HTA dossier to the Ukrainian HTA authority.  The assessment will be conducted by the authority, drawing on clinical, epidemiological, health economic and other information and methodologies.

Decision-making process

Decision-making on a MEA rests with the MOH. A MEA will only be executed following confidential negotiations between the MAH and representatives of the MOH.  The entire process (excluding HTA) to execution of a MEA may take over 1 year.  However, the Ukraine government has instituted statutory time limits for each stage of the decision-making process. For example, negotiations of a MEA should be limited to no more than 120 days, execution of a MEA should be limited to no more than 60 days, etc.

 Contracting parties

Once the key terms have been negotiated and agreed upon, a MEA can be entered into with respect to an original medicinal product and the following parties:

  • From the pharmaceutical company: MAH / its authorized affiliate / authorized distributor; and
  • From the Government: the MOH or State Enterprise “Medical Procurement of Ukraine” (if instructed by the MOH).

Term of a MEA

Managed entry agreements will be valid for a period of up to 1 year.  A MEA can be extended for additional 1-year periods, for a maximum of up to 3 years. Any extension of a MEA is contingent upon the receipt of a positive HTA.

A MEA can be terminated early in the event a generic product or biosimilar with the same INN, dosage form and/or therapeutic indication is authorized for marketing in Ukraine.

Key takeaways

Given the strategic importance of MEAs for innovative pharmaceutical companies, as well as the complexity and timeline of the HTA and MEA processes, it is recommended that pharmaceutical companies that have products that could potentially be subject to a MEA in Ukraine begin preparing for the HTA and MEA processes as soon as possible to minimize any potential for delay.

This post was written by Lisa Mueller and Viktoriya Podvorchanska at Asters

Ukraine Adopts a Bolar Exemption

June 5, 2020

On June 2, 2020, the Ukrainian Parliament passed a draft law introducing a legal exemption for patent infringement for actions relating to the development and submission of testing data to a Ukrainian regulator/authority for obtaining marketing authorization for medicinal products. These amendments were introduced to the Ukrainian Intellectual Property law entitled, “On Protection of Rights in Inventions and Utility Models”.  As a result, Ukraine law now contains a “Bolar exemption”.  More specifically, the new law excludes from infringement the importation into “…Ukraine, in accordance with the procedure established by law, of goods manufactured using the invention for the purpose of, and/or using the invention in, studies carried out with a view to prepare and submit  information for marketing approval of a medicinal product (based on the draft law presented for consideration of Ukrainian Parliament” (Please note that as of the date of this post that the final approved text of the law is not yet publicly available).

Previously, Ukrainian legislation and law did not contain a Bolar type exemption. Therefore, the issue of whether the early working (e.g., clinical studies, importation of samples and/or the submission of application for marketing approval) of a patented invention by a generic company could be considered a patent infringement was decided based on existing case law.  Although the practice varied somewhat, the prevailing position of the Ukrainian courts was that the start of any preparation by a generic manufacturer to obtain market entry constituted patent infringement.  Specifically, patent holders were often able to obtain injunctions during the term of a patent (a) when a generic company submitted an application for marketing approval to a Ukrainian regulator/authority (thus blocking or delaying the application at an early stage); or (b) once a marketing authorization was granted.  Despite this, the new law is expected to change this trend, thereby allowing generic companies to apply for marketing approval for a generic product before the expiration of a patent for purposes of commercialization after expiry.

From a formal perspective, the law requires execution by the (Ukraine) President as well as official publication to become effective. Additionally, as has happened previously in other jurisdictions, the breadth and specifics of the Ukrainian Bolar exemption will be further developed by future practice and case law.

Please continue to watch BRICS & Beyond for updates on the Bolar exemption in Ukraine.

This post was written by Lisa Mueller and Viktoriya Podvorchanska of Asters Law.