Medicines with empathy in action. The Ministry of Health has approved a Program for expanded patient access to unregistered medicinal products

It is a program to provide a compassionate use medicine for the treatment of inadequately treated moderate to severe neuropathic or nociceptive pain.

Order of the Ministry of Health of Ukraine No. 1607 dated 11.09.2023 “On Approval of the Program of Extended Patient Access to Unregistered Medicinal Products” provides an opportunity to treat inadequately treated moderate and severe neuropathic or nociceptive pain with medicinal products that are not registered in Ukraine but are used worldwide. The full text of the Annex and the medicinal products mentioned in it can be found at the link.

The First Deputy Minister Sergiy Dubrov is responsible for overseeing the implementation of this order.

What is compassionate medicine??

The Law “On Amendments to Certain Legislative Acts of Ukraine Regarding the Regulation of Provision of Compassionate Use Medicines to Patients”, which allows seriously ill patients to receive treatment with innovative medicines free of charge, was adopted by the Verkhovna Rada back in 2022.

The law increases access to innovative medicines for patients with severe disease stages, as well as to innovative medicines:

  • will reduce the cost of treating seriously ill patients for the state,
  • reduce the burden on the healthcare system to provide treatment to seriously ill patients,
  • will ensure the development of effective and efficient mechanisms for regulating relations with compassionate use programs.
  • An innovative drug under the compassionate use mechanism is allowed to be used in cases where:
  • there is no alternative drug for the treatment of the patient in the country;
  • the patient is in a serious condition or life-threatening;
  • the drugs have passed at least the first phase of clinical trials in the United States, the European Economic Area, Australia, Canada, Japan, the United Kingdom and the Swiss Confederation;
  • the manufacturer assumes responsibility for the use of the drug – provides data to justify the feasibility of treatment;
  • the patient provides a written consent confirming his/her awareness of the fact that the drug has not passed all stages of testing and agrees to use the medicine;
  • The Ministry of Health has approved a program for expanded patient access to unregistered medicines;
  • the decision to use the drug was approved by a doctor.

Such a mechanism is already in place in other developed countries, including the European Union and the United States, Canada, Japan, etc.

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