Legal Highlights: EAEU unified medicine and medical device market and parallel imports. Vladislav Vdovin and Galina Avdeeva for The Moscow Times

15.06.2017

On 26 April 2017, once the Kyrgyz Republic notified the Eurasian Economic Commission (EEC) that it had completed its domestic procedures, the unified EAEU medicine and medical device market came into operation. All medicines and medical devices are now to be registered under unified EAEU rules, followed by their simple, fast track registration in the member states.

The original launch date for the unified market was 2016, as the Agreements on common principles and requirements for circulation of medicines and medical devices within the EAEU were signed back in 2014. Even so, the process was put on the backburner until Armenia and Kyrgyzstan completed the formalities for acceding to the EAEU.

Under these agreements, unified EAEU registers will be launched of medicines and medical devices, the member states’ official pharmacopeias will be harmonised (the WHO has agreed to recognise the EAEU pharmacopeia as a regional standard of quality), uniform rules for pre-clinical and clinical trials and medicine registration will be established, as well as requirements on labelling, GMP (good manufacturing practice) and GDP (good distributional practice) rules and proper pharmacovigilance practices. The EAEU has also adopted basic criteria for classing medicines as prescription-only and controlled. Medical devices are now covered by uniform requirements on safety and effectiveness, special labelling and operating instructions, and other regulations, most having come into effect on 6 May 2017.

Under the EAEU rules for medicine registration, the formalities, including expert examination of medicines, must be completed within 210 calendar days of the application being filed (the period in Russia is a bit longer: 160 working days). Subsequent registration of a medicine in a member state will take up to 90 calendar days, providing there is no disagreement between the various registration authorities. Documents may also be submitted for parallel registration in the member state where the principal registration formalities are fulfilled and another member state within 210 calendar days.

Pre-clinical and clinical trial permits, pricing of medicines and medical devices, retail sale, regulation of medical advertising, public procurement of medicines and other procedures relating to reimbursement of medicine costs still come under the national regulations.

The anticipated benefits of lower medicine prices due to fiercer price competition should be carefully weighed against the risks of substandard medications reaching the market and lack of adequate control mechanisms.

Transition

Transition periods allow national mechanisms and pharmaceutical market players time to adapt to the new EAEU environment.

Registration dossiers of medicines registered in Russia before the Agreement on the unified principles came into effect must be aligned with the EAEU rules and requirements by 31 December 2025. Medicine registration certificates issued under the Russian legislation are valid until they expire, provided this is not beyond 31 December 2025. Medications registered in Russia and not aligned with the EAEU requirements may be sold on the Russian market after 31 December 2025 until their use-by date.

Registration of medicines under the EAEU rules is not yet compulsory. Until 31 December 2020, medications may be registered under Russia’s national rules and the registration dossiers may then be aligned with the EAEU requirements by 31 December 2025. If medication dossiers are submitted for registration before 31 December 2018, the manufacturer is also entitled to provide national documents issued in EAEU member states, instead of an EAEU GMP certificate, to confirm compliance with the national GMP requirements.

National registration certificates for medical devices will be valid in the relevant member states until they expire, but not beyond 31 December 2021. When registering a medical device before 31 December 2021, manufacturers may opt for either the EAEU or national rules.

Parallel imports

Despite the criticism of parallel imports, during its meeting on 26 April 2017, the EEC Board approved a draft Protocol Amending the EAEU Treaty and authorising the Eurasian Intergovernmental Council to apply the principle of international exhaustion of exclusive trade mark rights to certain types of goods, at the discretion of a member state. The document does not list products that are subject to this principle. The draft Protocol will be forwarded to member states for national approval by 1 July 2017.

Introduction of parallel imports has been under discussion in Russia for several years. Medical devices, medicines and car parts have been suggested as possible pilot groups of goods. The EAEU currently applies regional exhaustion of IP rights, so products may only be imported into the EAEU by holders of rights to the trade mark placed on the product or those authorised to do so by the right holder. If the EAEU starts applying international exhaustion, the IP rights will be exhausted allowing products to be imported into the EAEU once they have been sold by the IP owner (or with their consent) in any part of the world. This means that anyone can freely import such products, not just official distributors.

Let us note that opening the gates to parallel imports of medications and medical devices gives rise to a slew of practical concerns, in particular, about observance of the requirements on labelling, re-packaging (localisation) of medications, quality assurance, introduction of post-sale monitoring of quality and adverse reactions (pharmacovigilance), etc. Parallel imports are allowed in some mature economies but are often accompanied by additional statutory formalities that actually restrict uncontrolled importation of medications.

Extreme care should be taken if parallel imports are introduced for a category of goods that is socially significant and has direct impact on public health. The anticipated benefits of lower medicine prices due to fiercer price competition should be carefully weighed against the risks of substandard medications reaching the market and lack of adequate control mechanisms. One possible control method could be unique labelling of medications so that the entire manufacturer to consumer supply chain may be traced. This method is currently in use in the EU countries and is being tested in Russia.

https://themoscowtimes.com/articles/eaeu-unified-medicine-and-medical-device-market-and-parallel-imports-58191

Contact details

For all issues related to publications, news and press releases, please contact:

Ksenia Soboleva

Head of PR and Communications

Subscription

If you would like to receive our legal alerts and updates highlighting current legal issues relevant to your areas of interest and providing expert commentary by our lawyers, please click on "Sign Up" and fill out the form.