The Draft Law on Medicinal Products (registration No. 5547) is currently pending in the Ukrainian Parliament (Verkhovna Rada). There are several factors suggesting that this draft law should be taken as seriously as possible: firstly, the draft law was signed by 22 MPs from different factions and groups, including M. Radutskyi, Chairman of the Sectoral Committee, and, secondly, the draft law has already been approved in the first reading.
The draft law, among other things, significantly amends the procedure for and validity period of state registration of medicinal products and the conditions and period of time for protection of registration data.
Both the procedure and the validity period of the state registration of medicinal products as well as the time period and conditions of protection of registration data (data exclusivity) are essential to the pharmaceutical industry.
State Registration Procedure
As before, state registration in Ukraine remains a mandatory condition for bringing a medicinal product to the Ukrainian market (with a few exceptions).
At the same time, the draft law, unlike the current legislation, does not contain a simplified procedure for registration of medicinal products registered in the EU, USA, Canada, Japan, Switzerland, and Australia. As an alternative, the draft law provides for state registration of medicinal products under a mutual recognition agreement with another state. However, to put this mechanism to work, it is necessary not only for Ukraine to recognize the registrations made in the states with a strict regulatory system (USA, Canada, etc.), but also for these states to recognize the Ukrainian registration.
It is only business companies registered in Ukraine or in a EU member state that will be able to register a medicinal product in Ukraine. To put it differently, the manufacturers of medicinal products from other countries will have to register a legal entity in Ukraine to do their business in Ukraine. If an applicant is from the EU, it will have to appoint its representative – a Ukrainian company by entering into a written agreement with it.
Validity of State Registration
Pursuant to the law currently in effect, marketing authorizations for medicinal products in Ukraine are initially valid for 5 years. The medicinal product can then be re-registered and such registration will be valid indefinitely. However, Order No. 426 of the Ministry of Health of Ukraine allows to re-register medicinal products for 5 years only, which is sometimes the case in practice.
Pursuant to Directive 2001/83/EC, a marketing authorization is initially valid for five years, with subsequent marketing authorizations valid for a indefinite term or renewed for 5 years.
The draft law introduces a slightly different model: the first registration shall be valid for 5 years, the first re-registration shall be valid for 5 years, the second re-registration shall be valid indefinitely or for 5 years (this will be decided based on the expert assessment results).
This gives rise to the following question: what will happen to those marketing authorizations that were or will be registered before the entry into force of the new law?
The new law is expected to enter into force on the date of publication and will be enacted 12 months thereafter. A medicinal product marketing authorization issued under the law currently in effect and having a limited period of validity will be effective during the period stated in it.
While a marketing authorization issued under the law currently in effect and having an unlimited period of validity will remain effective for 5 years after the new law enters into force.
Thus, all medicinal products will require new registration and a transitory period will be:
- for medicinal products registered for an unlimited period, 5 years after the new law takes effect;
- for medicinal products registered for a limited period, until their period of validity expires.
By way of comparison, the Law on Veterinary Medicine suggests a simplified procedure to re-register veterinary products under the new law, i.e., by adding to the registration dossier the information that is missing to meet the requirements set out in the new law (clause 4 of the Final and Transitory Provisions). The Draft Law on Medicinal Products provides for nothing of a kind.
Registration Data Protection Period for Reference Medicinal Products (Data Exclusivity)
Neither the draft law nor the law currency in effect lists countries where reference medicinal products must be registered for the purposes of registration of a generic product. So, it looks like a generic product may be registered in Ukraine in relation to a reference product registered in any country of the world (provided that its bioequivalence has been proved). However, for the purpose of registration of a generic product in the EU, a reference product may be a medicinal product that has been registered in the EU only.
The statutory protection period for registration data (data exclusivity) for reference medicinal products is essential for manufacturers of proprietary medicinal products not only but those manufacturing generic products as well. Under the applicable law of Ukraine, this period is 5 years (it may be sometimes extend to 6 years). In the EU, the data exclusivity has two elements: the period during which a generic product may not be applied for registration (data protection) and the period during which a generic product may not be sold (marketing protection). The former period is 8 years and the latter period is 10 years and, sometimes, 11 years after the date of registration of the reference medicinal product.
The draft law clearly tends to implement both the data protection (article 42 (1) of the draft law) and marketing protection (article 42 of the draft law) but the period for both the first and the second elements is the same – five years. However, as always, the devil is in the details, that is, the way how to calculate such period. The draft law states that it should be calculated “from the date of the decision on state registration in Ukraine as the country of the first registration of the reference medicinal product with a full registration dossier or the date of the decision on state registration in the European Union for the reference medicinal product authorized in the European Union with a full registration dossier.”
Given this, several conclusions may be drawn:
1) data exclusivity will be effective only in relation to a reference medicinal product registered in Ukraine, for which Ukraine is the country of first registration;
2) data exclusivity will apply to a reference medicinal product registered in the EU and, accordingly, will not apply to reference medicinal products registered in other countries.
Moreover, draft law provides that there will be no data exclusivity if a reference medicinal product is applied for state registration in Ukraine one year after the date of its first registration in any country. We believe that this sentence is contrary to the above, i.e., if the draft law states that the data exclusivity is applicable only to those reference medicinal products registered in Ukraine, for which Ukraine is the country of first registration, then it does not matter, for the other reference medicinal products registered in Ukraine, how many years have elapsed after the first registration. The draft law seems to need to be finalized to such extent.
Furthermore, the data exclusivity will not be applicable if a medical product registered in Ukraine with a full registration dossier is proved to be essentially a generic product in relation to the reference medicinal product already registered in Ukraine or EU country. Notably, the other countries are not mentioned here.
Thus, there will be no data exclusivity if the Cabinet of Ministers of Ukraine authorizes using a patented invention (utility model) for such medicinal product. This is a somewhat extraordinary rule, especially in view that the patent protection has nothing to do with the data exclusivity, and vice versa.
What to Do?
Both the procedure and the validity period of the state registration and the data exclusivity are essential to the pharmaceutical industry. To such extent, the Draft Law on Medicinal Products implements the EU legislation partially only.
However, the proposed changes should not be treated as a rule set in stone – many legislative initiatives are often changed and modified while the draft law goes from registration and the adoption in the Verkhovna Rada and signing by the President. It is often the case in view of the initiative of active business and its legal advisers.
We urge the business community and other market players not to be indifferent to the future “rules of the game.” There are only 14 days (till 29 September 2021) to submit amendments to the second reading.