Shortages of vital medications and inflated prices are all very much to the liking of pharmaceutical monopolists and corrupt officials. That's why they're resisting the law simplifying state drug registration. Access to medications and medical supplies on the Ukrainian market is utterly corrupt. This results in inflated prices, a shortage of effective medications, and a limited selection.
And so, on June 16, 2016, Ukrainian President Petro Poroshenko signed the law "On Amendments to Article 9 of the Law 'On Medicines' Concerning the Simplification of State Registration of Medicines"—the document was adopted by the Verkhovna Rada on May 31, 2016. By signing the law, he clearly outlined the goal to be achieved: "We are closing yet another channel for financing corruption in Ukraine, and this also has obvious advantages. Leading pharmaceutical companies, which for ethical reasons refused to pay bribes, will finally be able to come to Ukraine. Today, the gates to them—the honest and decent—are open in Ukraine."
As for quality, we're talking about drugs that are manufactured, registered for use, and used in countries with strict regulations: the United States, Canada, Australia, Japan, Switzerland, and those registered in the European Union through a centralized procedure. Let's keep this in mind—it's important.
The day after the law was signed, during a visit to the Ministry of Defense's Main Military Clinical Hospital, Poroshenko made an extremely blunt statement: he declared that implementing the law would make "a small, but very important step toward making medications cheaper and more accessible, and preventing the criminal mafia from profiting from it." He immediately instructed Acting Minister of Health Viktor Shafransky to prepare the relevant regulations within a week to ensure the law's implementation.
But apparently, this state of affairs doesn't suit everyone in the pharmaceutical market—someone has emerged who wants to, if not halt, then at least emasculate the ongoing reforms. And now, Anatoly Reder, CEO of the pharmaceutical company InterChem, is threatening Ukrainians with higher drug prices.
"Since the adoption of Law No. 4484 will require Ukrainian pharmacists who supply medications that are, on average, five times cheaper than imported ones to register their products for one and a half to two years, while foreign manufacturers will be able to complete the registration process in 10 days, this will lead to higher prices for the average package of medications sold," UNN quotes Reder as saying. "We will all see this for ourselves in a year. People will be forced to buy expensive medications because domestically produced pills, five times cheaper, will have to wait another 1,5 years for registration. This is a matter of equality of opportunity. The state is creating problems for its own manufacturers and depriving citizens of access to affordable medications."
Judging by the frequency of repeated publications quoting Anatoly Reder, a rather powerful campaign is underway to discredit the idea of a simplified registration regime for drugs registered in countries with strict regulations. And, of course, Reder's distortions are impressive: according to UNN, he even expressed concerns that, as a result of the relaxed quality requirements for imported drugs, drugs of dubious quality from third-world countries could enter Ukraine.
However, as stated in the law, this only applies to drugs that are manufactured, registered for use, and used in countries with strict regulations. This means there is no mention of any "third world" drugs.
The campaign has been ongoing for several weeks now – its organizers are unfazed by the unequivocal support of both the President and the Prime Minister. At one of the first government meetings in April, Volodymyr Groysman stated: "With its first decision, the new government immediately took a step toward introducing a simplified drug registration mechanism in Ukraine. Specifically, the Cabinet's decision just adopted applies to drugs that have already been certified in the United States, the EU, Switzerland, Japan, Canada, and Australia. We trust the expertise of these countries, and there is no need for lengthy assessments in Ukraine."
At the same time, the government decided to implement a number of measures that would reduce the cost of medicines in Ukraine:
"Among the priority steps approved by the government are: reducing the timeframe for drug evaluations, revising contract limits, and revising packaging requirements to make medications cheaper for Ukrainians. Demonopolization and deregulation of the pharmaceutical market will expand access to quality medications on the Ukrainian market, increase competition, eliminate corruption, and ultimately lead to lower prices," stated Volodymyr Groysman. "This is the path we will continue to follow."
The government initiative, as is well known, received strong support in the Verkhovna Rada. Oksana Korchynska, MP and First Deputy Chair of the Verkhovna Rada Committee on Healthcare, explains why: "Only those producing low-quality medications need fear [this law], as expanding our product range with European and American drugs will force such companies to reconsider their production approach. We need to significantly expand our product range; all of our European neighbors have a much wider selection of medications." Oksana Korchynska is confident that the law will have a beneficial effect not only on product range but also on prices: "This won't lead to an immediate drop in prices, but when foreign companies realize they can supply their medications to Ukraine without corruption, it will significantly ease the lives of seriously ill patients and, at the very least, will help keep prices down thanks to intense competition."
Leaders of public and patient organizations have responded positively to the new procedure. For example, Irina Litovchenko, co-founder of the Tabletochki charitable foundation, is confident that "This law will in no way negatively impact the Ukrainian pharmaceutical market. On the contrary, it will have at least two effects: first, medication prices will decrease, which is extremely important, as previously, Ukraine had a number of drugs of substandard quality that were sold here, but our pharmacists prevented good, high-quality European equivalents from entering the market. Now, we will be able to import and use these drugs. Second, approximately 15-20% of cancer treatment drugs are not registered in Ukraine, and we, volunteers, were forced to smuggle them in from abroad, violating the law. And the doctors who used these drugs for treatment were essentially also breaking the law. Now that these drugs can be legally imported into Ukraine, we won't have to devise any schemes or resort to any tricks. Thirdly, this means access to various developments. Previously, newly developed drugs would only appear on our market after many, many years, but now all the latest medications can be imported into Ukraine and made available to our patients."
Litovchenko also expects a positive impact on pricing: "If you look at the market in Georgia and Bulgaria, the price of one drug there is 30-40% lower (than in Ukraine), while another is 2-3 times lower. The problem with expensive and rare drugs was that it was difficult to supply them to Ukraine."
The co-founder of the Tabletochki Charitable Foundation expects the new procedures to be launched soon so they can be used to provide the most critically ill patients with life-saving medications: "The order has already been posted on the Ministry of Health's website, so there are still a few questions for the State Drug Control Service and other organizations. Once all the regulations are signed, we'll be able to purchase medications normally. For now, the law isn't in effect. But my colleagues and I have already written a huge stack of letters to all European manufacturers, and as soon as these regulations are adopted, we, as representatives of patient organizations, will send these letters to the manufacturers and ask them to bring their medications to Ukraine."
Inna Boyko, a representative of the Patients of Ukraine Charity Foundation, agrees with Irina Litovchenko: "Currently, many patients, especially cancer patients, suffer due to the lack of many vital treatment medications on the market. Many medications needed by cancer patients are impossible to obtain in Ukraine; they are simply not available on the market because they are not registered. This leaves patients with two options: they can either buy these medications on the black market, further risking their health, as few will take responsibility for the quality of these medications. Or they are forced to import the medications individually, which is an extremely complex and time-consuming procedure."
"The adopted Law No. 4484 opens the door to the market for medications that have been vetted by the world's best regulators, who will not allow themselves to register drugs of dubious quality," a representative of the Patients of Ukraine Charitable Foundation is confident.
Inna Boyko particularly emphasizes that immediately after signing the law, the President demanded that the drafting of bylaws be completed within a week (that is, by June 23-25) so that the law could be implemented. However, according to her, as of July 5, only one bylaw (regulatory act) had been drafted: "We, for our part, actively intervened to expedite these final procedures as much as possible."
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