Open letter from Ukraine

Open letter from Ukraine:

“The proposal for a new IP strategy of Ukraine prioritises public health
and national security during the war”

As Russia’s full-scale invasion of Ukraine enters its third year, Ukraine is set to revise its intellectual property (‘IP’) strategy 2024-2030. The challenges in preparing the new IP Strategy are unique. As the number of patients with war-related injuries increases, so does the need for essential medicines. Ukraine also needs to maintain sufficient supplies of life-saving medicines for patients with serious infectious and chronic conditions. In light of this, the main strategic goal of Ukrainian policy during this war must be the protection and strengthening of national security in the field of healthcare thereby securing the national interests of Ukraine by protecting the life and health of its population. The IP system of Ukraine must work to ensure that this goal is achieved and must become a vehicle for the promotion of public interest.

The proposals for the new IP Strategy of Ukraine, therefore, are focused on accelerating access to essential medicines during the war, including

  • eliminating the obstacles for generic competition,
  • allowing import of affordable medicines, and
  • facilitating the national production of essential medicines.

These measures take into account the relevant legal and financial restrictions during the period of martial law in Ukraine; they are also in line with Ukraine’s international obligations under the TRIPS Agreement and its EU accession commitments.

It is proposed to revise the current Ukrainian domestic IP law mechanisms, including

  • broadening the scope of the Bolar exemption;
  • removal of patent linkage;
  • facilitation of parallel importation, including via clarifying the rules of international IP exhaustion;
  • maintaining the current period (5 years) of data exclusivity until Ukraine joins the EU;
  • examination of pharmaceutical patent applications following UNDP Guidelines; and
  • a more rigorous investigation of IP-related pharma practices by the Antimonopoly Committee of Ukraine.

In addition, the proposals include the implementation of effective legal mechanisms that would allow accelerated access to essential medicines when needed. This includes the revision of the compulsory licensing and government use system to make it more workable. Furthermore, to ensure access to life-saving medicines during the war, Ukraine should utilise the specific security exceptions provided in Article 73 TRIPS that allow a WTO member to implement measures to protect its essential security interests in wartime. Today, the essential security interest of Ukraine is the protection of life and health of its people. Relying on this Article 73 TRIPS exception, Ukraine can suspend certain IP rights that protect life-saving medicines and medical devices for the duration of the war; this, in turn, will allow domestic production and import of generics and biosimilars without the risk of infringing any IP rights. Article 143 of the EU-Ukraine Association Agreement contains the identical security exception. During emergencies (such as wars and pandemics) public health concerns must prevail over private interests, and countries at national, regional (EU) and global (INB) levels must utilise all tools available in international law to protect their people.

Considering the gravity of the situation with the supply of essential medicines during the ongoing illegal Russian aggression against Ukraine, the above proposed measures are necessary, proportionate and justifiable, as well as in line with the domestic and international obligations of Ukraine. More importantly, these measures will help to save tens of thousands of lives, both military and civilian.

We call upon the international community of experts and scholars to support our proposals by signing this letter:

The working group:
Team Leader: Anton Kapitonenko
Experts: Olga Gurgula, Oksana Kashyntseva, Anastasiya Homeniuk

The proposals of the working group are prepared in collaboration with the Ministry of Economy of Ukraine and the national IP office as part of the TIPSTER project. The project is being implemented by the Foundation for support of reforms in Ukraine with financial support from the Government of Germany under the international cooperation project ReACT4UA (“Application and Implementation of the EU-Ukraine Association Agreement in Trade”), executed by the German federal company Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ) GmbH. The project aims to enhance the competitiveness and resilience of Ukrainian small and medium-sized enterprises, particularly in view of EU accession.