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Goodbye, substandard drugs? Who will determine how to cure Ukrainians

Goodbye, substandard drugs? Who will determine how to cure UkrainiansVery few people buying drugs from a pharmacy or looking at the doctor’s recipe, think about what they are really buying. And they should not do it - it is the work of pharmacists, not patients.

It is their duty to say what drugs are effective and what substances are simply a marketing product of advertising some strange mixture of liquids form rhino or elephant, able to save miraculously all diseases.

The problem of substandard or ineffective medicines or those too expensive to be used should be solved only with the introduction of the unique state list of drugs.

The drugs that are not included in this list cannot be purchased for the state budget, and in some countries, it is forbidden for the doctors to prescribe them to the patients: the specialists can only recommend them.

As a result, these lists began to beat the pockets of the pharmaceutical companies.
The World Health Organization has established the first drugs’ list in 1977. It was intended to show in which medicines the combination “value/money” is the best.

The list was formed according to three basic principles: clinical evidence base, availability of the drug in the protocols of treatment in different countries and pharmaco-economic criteria - which medicines are the most appropriate from an economic point of view.

Realizing that even the richest countries cannot afford to treat the patients with very expensive medicines, pharmacists and physicians took to analyze, what is better to apply for certain ailments.

How it works in Ukraine

In Ukraine there are several drugs’ lists used by healthcare institutions: State Form of Drugs, National list of medicines and list of drugs that can be purchased by the health care budget.

One of them includes all the drugs registered in Ukraine. Even those which would be considered abroad as biologic active supplements, are being gladly bought in Ukraine at the expense of the State budget.

For example, the market leader in retail networks is a drug "Aktovegin". It is bought not only by the patients at their own expense, but almost by all the hospitals in Ukraine: millions of grivnas are spent annually for it.

However, this is almost the only drug that has no registered chemical formula. The basis for its preparation is the extract from bovine blood, it means, it is filtered calves’ blood. In the same "effective" way in the 1930s tuberculosis was treated by using dog fat.

Because of the big number of lists in Ukraine specialized hospitals usually buy a "non-core" products.

So, psychiatric hospitals - with minimal budgets - do not buy drugs to treat psychiatric conditions and diseases, but hepatoprotectors or antibiotics. Although at first the doctors should treat the disease, and only then the disease related conditions.

Everything which is on the shelves of distributors, is being bought in Ukraine. Normally the sales representatives come to the chief doctor with the list of specific residues that are in storage, and that as the way in which the order goes to the nomenclature, this is how the list of drugs which will be purchased is determined in our country.

Now, with the unique clear drugs’ list, it will be much more difficult to sell unneeded drugs.

What do they want

40 years after the civilized world had the idea of a single drug’s, this mechanism finally will be applied in Ukraine as well.

The competition of experts’ election - those, who will form the list – is furious because on their decisions will depend profits of the pharmaceutical companies.

In 2015, when the idea to translate and to take as the base the drugs’ list of the World Health Organization was proposed, there was much noise and scandal around the situation. They say that Ukraine needs its own drugs’ list, and all the international experts could not dictate their rules.

30 candidates have applied for the 12-18 vacant seats of experts who will form the national drugs’ list. More than half of them, 18 people are the representatives of the State Expert Center.

This is a government agency under the Ministry of Health, which decides which drugs can be put on the Ukrainian market, and which should be banned.
However, many of these experts have a conflict of interest because they are associated with different groups or pharmaceutical pharmacy businesses.

For example, Marina Doodlei worked for five years as the Head of the pharmacy "Falbi" and Miroslava Jaremenko was the official representative of this pharmacy network.

The former President of "Falbi" Michael Pasechnik is the associate of Petro Bahriy, the President of Association of Drugs’ in Ukraine.

It was Bagriy who during the leadership of the Minister Oleg Musiy made the appointment of Michael Pasichnyk at the position of the Head of the State Service for Drugs. Elena Alekseeva was appointed as the Vice of Pasichnyk: she is the former director of the Association of Medicines of Ukraine under the presidency of Petro Bagriy.

This association includes the majority of Ukrainian producers. They are interested in the fact that their drugs should be in the single drugs’ list that will be bought by the State. They are also interested to produce the drugs which will be on the list.

The abovementioned Petro Bagriy is also the exclusive supplier of many drugs of the foreign pharmaceutical companies, which are being re-packed at his plant "Lyumyer-pharma".

The name of another expert should be also mentioned - Vladislav Onishchenko. After working in a managerial position in the State agencies, he decided to found public organization "Union of Consumers Of Medical Services".

Prior to that he was the Chief inspector of Ukraine or the quality control of drugs.

Interestingly, the co-founder of his organization were people closely related to the pharmaceutical business. One of them is Igor Vovkodav who owns - or is related through his relatives - to 14 pharmaceutical companies or firms that provide services to them. Vovkodav manages the company "Pharm-ROST", which provides services to promote drugs on the market. So, the conflict of interests in the case of Onishchenko, whose business partner is promoting drugs, does exist.

In addition, it is unknown how Onishchenko wants to get to the Expert Committee, if the Ministry of Health’s document clearly states: the experts should work in health care, higher medical school or research institution. That automatically excludes from the list the members of the public.

A conflict of interest exists as well between Zaporozhye scientists. For example, Olga Hetalo forgot to indicate in her resume, that she is the owner and Director of the production society "Virgo", whose main occupation is retail sale of pharmaceutical products.

We should not forget about a separate group of experts associated with the Zhytomyr. Thus, Sergey Grischuk and Valentin Pariy represent one organization known as "Health Insurance of Zhytomyr Region". Pariy is the Chairman of the board, and Grischuk is Deputy Executive Director.

Academic Pariy also has a small business with the executive director of "Health Insurance" - "Euro BB", so, as we see, these community activists and academics are connected not only by the scientific interests, but also by business interests.

There are some other representatives of Zhytomyr organizations - Olga Stetsyuk from the NGO "Union of Workers Of Pharmacy", but she is unlikely to win the place - the public people are not allowed to participate in the elections.

The experts who represent Lviv Medical Universitya are also interconnected. Among them Zimenkovsky Andrew, the Head of Clinical Pharmacy, Pharmacotherapy and Medical Standardization, the son of the Rector of the university and his subordinate Juliana Yanyshyn.

According to the address indicated in the registration form, another person with the same surname (Zimenkovsky), but with other initials - Vladimir O. Zimenkovsky. The latter is the owner of LLC "Scientific Center "Labofarm".

And the Head of the Chair himself once was the assistant of the deputy Michael Syatyn who has a pharmaceutical business, being the co-owner of "Ukrainian Pharmaceutical Center" LLC "Ukrfarmo", LLC "SI B. trade", while his wife, along with Slovaks is a co-owner of Ltd. "Medical Transkotrakt-Ukraine".

The main problem the new created body - the lack of equal representation of different groups. For example, the Association of domestic producers may take place as part of the working group, but it must be balanced by the representatives of the Indian companies or companies producing innovative medicines.

The representatives of health and patients' associations are not in the list, and they probably do not even know about the creation of this group.

Almost all the Central Formulary Committee of the Ministry of Health, which forms the national form, moves to the new body, which is a direct conflict of interest. And it is unclear what will be the difference between it and the Formulary Committee.

There is the ongoing monopolization of the market, because the same people form all drugs’ lists in the country and they are also responsible for the implementation of their provisions.

Thus, the six members of the Central Formulary Committee submitted the documents submitted to the Expert Committee for the forming of the drugs’ list. Among them - Valentine Pariy, Dumenko Tatiana, Tatiana Kovalchuk, Olga Sadovnichaya, Larisa Yakovleva and Elena Matveeva. All but Pariy and Yakovleva, are the employees of the State Expert Center.

The question arises. Will Central Formulary Committee be disbanded? The people elected to the Expert Committee will come out of it or, as usual, one and the same people will occupy space here and there?

In the current forms and national drugs’ lists there are trade names of drugs, the purchase of which is prohibited by the national law, and still domestic manufactures are leading there.

For example, the Odessa Medical University plans to buy "Prednisolone" produced by the company "Darnitsa" and the Ukrainian Research Center for endocrine surgery, endocrine transplantation of organs and tissues of the Ministry of Health of Ukraine - the drug "Lesfal". The latter is a non-prescription drug, actually it is biological active supplement and produced by the same manufacturer - the company "Farmak".

The list of Experts shows a clear case of monopoly: for decades there the same names engaged in the formation of the drugs’ lists, like, for example, Petro Sereda, the Head of the State Scientific and Expert Centre of medicinal products. He has been involved not just in expertise, but in the scientific expertise since 1999 when the Ministry of Health reorganized Pharmacological Committee of the Ministry in the state enterprise - the State Scientific and Expert Centre of medicinal products.

Interestingly enough, during the competitive selection process in the requirements it was stated on compulsory lack of communications of the experts (for the past four years) with the pharmaceutical companies. It can be found in Annex 1. However, one of the candidates - Oresta Spinyazhko - in 2015 worked in the company "Actavis".

So, all whose who rushed to form the "new list" are either representatives of the old "expert" groups or representatives of businesses or pharmaceutical lobby.
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