Use of foreign treatment procedures in Ukraine: hidden and inaccessible aspects become real and official

20-04-2017

The BRDO has been successfully cooperating with the Ministry of Health of Ukraine in many initiatives related to creating better business regulation for a long time. However, one of the problem, which the Ministry of Health asked our Office to deal with, was a real challenge for us: this is a problem of outdated and imperfect Ukrainian healthcare protocols.

REALITIES OF UKRAINIAN PROTOCOLS

Nowadays, physicians have to treat their patients according to “unified clinical protocols of medical care” – the documents describing how to cure a particular disease. Disadvantages of Ukrainian protocols are:

  • inconsistency with leading foreign analogues – because of a specific character of the Ukrainian rule-making process, domestic protocols often include the instructions, which do not meet the best international practice. The reasons are different. One of them could be the fact that the inclusion / non-inclusion of a pharmaceutical product into the protocol directly affected the possibility to purchase related medicines and the volume of their sales.
  • obsolescence – amending protocols requires a considerable amount of time and efforts, and Ukrainian protocols sometimes fail to be updated according to new achievements of modern medicine;
  • a lack of coverage – there are diseases, the treatment of which was not regulated by Ukrainian protocols, although appropriate protocols would be really useful.

Of course, doctors speaking a foreign language are able to read in what way a particular disease is cured in developed countries. However, no legal act provides for their right to apply modern methods of treatment, which are used in the Western world but do not meet the requirements of Ukrainian protocols. Moreover, Article 14-1 of Fundamentals of Health Legislation of Ukraine explicitly prohibits this right.

ACCESS TO THE BEST INTERNATIONAL PRACTICES

The obvious solution to the above mentioned problems could be the updating of Ukrainian protocols. We hope that the Ministry of Health together with the specialists of the Academy of Medical Sciences of Ukraine and other leading Ukrainian experts will be able to implement this step.

However, unfortunately, this approach does not solve the problem in the near term and, probably, even in the medium-term perspective. The updating of protocols requires a considerable amount of time, efforts and money. At the same time, the life and health of patients require the immediate response to this problem.

Therefore, a prompt response to the defined problem was the decision of the Ministry of Health to officially grant Ukrainian physicians the right to directly use foreign treatment protocols, which will be selected by the Ministry of Health (and that will provide the access to them). This order will be published in the coming days.

Foreign protocols selected by the Ministry of Health will have the same status of “clinical protocols” (according to Article 14-1 of Fundamentals of Health Legislation of Ukraine) as existing national standardized clinical protocols.

On the one hand, this approach protects physicians who will apply foreign protocols. After all, they will apply not just the foreign experience, but also the document that has a status of sectoral standard in the healthcare system.

On the other hand, there can be a situation (and most likely, it will appear again and again), when a foreign protocol conflicts with its Ukrainian analogue. Which protocol should a physician choose?

Physicians themselves will provide an answer to this question in each particular case – they will have a legal possibility to choose a foreign protocol. This possibility of physicians will become their duty when there is no Ukrainian protocol on certain disease, but there is a foreign protocol translated into Ukrainian by the Ministry of Health.

Moreover, the use of foreign protocols (if there are their Ukrainian analogues) is possible just with a written informed advance consent of patients.

RISK ASSESSMENT

It should be understood that a permission to apply foreign protocols affect interests (including the economic ones) of an extremely wide range of healthcare market participants. And these interests not always coincide with concerns for public health. Therefore, anticipating a round of criticism, it should be mentioned that developers of the draft order of the Ministry of Health, which allows to use foreign protocols, are fully aware that:

  • Some (not many) physicians currently use foreign protocols and violate the Ukrainian protocols by this activity. However, from now on, they can do it officially and not fear sanctions from the state;
  • Not all foreign protocols can be implemented in Ukrainian realities. However, now physicians can choose the closest possible analogue or send a patient to an institution where it is possible to apply a foreign protocol;
  • It is difficult to force Ukrainian physicians to adhere to Ukrainian protocols, saying nothing of the foreign ones. However, this does not mean that we should tie the hands of the best representatives of this profession;
  • There is a risk that physicians will misunderstand protocols written in a foreign language. However, patients will be aware of this risk and make their choice through their informed advance consent. In addition, it is better to use a foreign protocol improperly in some cases than always use a Ukrainian protocol in improper way.
  • Foreign protocols also are not perfect while being sometimes a result of lobbying activities of pharmaceutical companies. However, it seems that protection mechanisms against unjustified lobbying are much better developed than ours. At least, you get this impression after comparing some Ukrainian and leading western protocols.

Good health to you!

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