Apr 08, 2020

The country’s pharmaceutical safety program, developed with the participation of the President of Ukraine, will secure from the shortage of vital medicines caused by the pandemic

Farmak, as a member of the European Generic Medicines Association (EGA) – Medicines for Europe – and the Association of “Manufacturers of Drugs of Ukraine” (the AMDU), advocates for the creation of a coordination group at the Office of the President of Ukraine to prevent a shortage of medicines in Ukraine during the pandemic.


Today, the Ukrainian Health Care System is facing unprecedented challenges amidst the coronavirus pandemic. The most critical issue is the integrating efforts of the authorities and national manufacturers of medicines and medical devices, as Ukraine cannot count on anyone but itself. Today, almost all countries in the world are in the same crisis. One of the key issues to deal with is the prevention of a shortage of medicines in Ukraine. It is not only about medicines aimed at fighting coronavirus infection, but also about vital medicines for patients with acute and chronic diseases. Responding promptly to these challenges will help save lives and minimize the pandemic severity and consequences.


“EU countries actively work on the issue of the shortage of medicines and ingredients for their production because of the pandemic. The problem is also inevitable for the Ukrainian realities, unless we start working together today. Farmak is the member of the European Generic Medicines Association – Medicines for Europe, which today actively cooperates with the European Commission and the European Medicines Agency on ensuring the stability of medicines supply to hospitals and pharmacies. We participate in the discussion of urgent problems in the field of regulation, production and supply of medicines in Europe, speak similar problems that exist in Ukraine, and receive copies of all relevant applications to the European Commission, EMA (European Medicines Agency). Today the membership in Medicines for Europe gives us an opportunity to be aware of the problems that Ukrainian medicine, and in particular the pharmaceutical industry, will face, since the epidemic in the EU has started earlier. And what is important for us right now is to be proactive,” – said Vitaliy Usenko, Medical Advisor, Pharmak JSC.

Today the negotiations with the government of India to prevent supply disruptions (not only ban on certain groups, but also the development and logistics of APIs (active pharmaceutical ingredients) without prohibition) of active pharmaceutical ingredients for the production of medicines, especially for intensive care (EU satisfies its demand by about 35%, while importing ingredients from India only up to 35%), put among other issues on the agenda of the European Commission and mentioned European Association. They discuss most actively the availability of medicines for intensive care: anesthetics, narcotic drugs, muscle relaxants, which enable the function of RMD (respiratory medical devices). This also applies to other key raw material suppliers, such as China and USA. In most countries, special committees have been set up to control, manage and secure the supply of APIs for the smooth functioning of the pharmaceutical industry. The European Commission and the governments of the Member States consolidate efforts to optimize the allocation of resources, the “inventory” of substances and finished medicines, the rapid import of ingredients and the production of medicines according to the priority hospital needs.


“We offer to adopt experience of coordination activity of Medicines for Europe, the European Commission and EMA. Thus, we need an operational working group headed by the Office of the President of Ukraine, with the participation of medicines manufacturers, the Academy of Medical Sciences, medical institutions, the National Security and Defense Council of Ukraine, the Ministry of Health, the Ministry of Foreign Affairs, customs authority, etc. The government should take the lead in this process. Actions can also be coordinated with the European Commission and Medicines for Europe, because they are one step ahead, as they had an epidemic before us and because they have strong positions in the international political arena when it comes to negotiations with countries supplying raw materials for production of medicines”, – said Vitaliy Usenko.


Farmak supports AMDU’s recommendations on the prevention of shortage of medicines in Ukraine:


to draw the authorities’ attention to the threat of a shortage of medicines in Ukraine in the near future as a result of coronavirus epidemic. Namely:

  1. to keep at the national level a balance of manufacturers’ stock of required APIs for hospital needs (muscle relaxants, anesthetics, narcotic drugs, etc.);
  2. to analyze and to systematize information on the manufacturing capacities of medicines manufacturers for vital medicines and intensive care medicines;
  3. to make customs clearance of all APIs a priority, and not just those used to fight the spread of coronavirus infection;
  4. to simplify and to significantly shorten the procedure time for modifying the dossier of medicines for the replacement of APIs or auxiliary ingredients, type of packaging, etc.;
  5. to conduct negotiations on behalf of the government with the governments of the partner countries on the unblocking of export of key APIs;
  6. to negotiate on behalf of the government with key air carriers about the inadmissibility of refusing to transport the APIs; the option of obligatory setting quotas without raising the cost of such transportation;
  7. to use other tools offered within consultations with medicines manufacturers.

In the light of the experience of collaboration between Medicines for Europe, the European Commission and the EMA, we propose to consider the following steps to coordinate work on prevention of a shortage of medicines in Ukraine during a pandemic:

  1. to appoint a responsible person from the Office of the President of Ukraine, who will coordinate the work in this respect;
  2. to establish a coordination task force with the involvement of CGB (Central Government Bodies), industry associations and medicines manufacturers;
  3. to establish monitoring of the hospitals’ key needs for medicines for urgent needs, surgeries and patients with chronic illnesses;
  4. to establish contacts with key responsible persons on this issue in the European Commission (we can request these contacts in Medicines for Europe); to join on behalf of the state of Ukraine the European Commission’s negotiations with the governments of foreign APIs’ suppliers.


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