Representatives of the medical and pharmaceutical community opposed the law No. 11493 on the regulation of the pharmaceutical market. They called on the President of Ukraine Volodymyr Zelenskyy to veto the document because of the negative consequences for Ukrainian patients that the updated regulation may lead to, UNN reports.
"We represent all parts of the drug circulation in Ukraine - drug manufacturers, importers, distributors and pharmacies that work every day to provide patients with the necessary pharmacotherapy of Ukrainian and international origin. Unfortunately, each of these communities sees significant risks of destabilization of the pharmaceutical market and shortages of various categories of medicines in Ukraine in the adopted draft law. The goal underlying this initiative - reduction of prices for medicines - obviously cannot be achieved by the provisions established by the Law of Ukraine," reads the letter obtained by Apteky.ua.
Open letter to the President signed:
- CEO of Proxima Research International Yevhen Kunda;
- Volodymyr Redko, Executive Director of the Association of Pharmaceutical Research and Development (APRaD);
- Volodymyr Ignatov, Executive Director of the Association of International Pharmaceutical Manufacturers (AIPM Ukraine);
- Executive Director of the European Business Association, Anna Derevyanko;
- Tetiana Kotlyar, Head of the All-Ukrainian Pharmaceutical Union “Pharmukraina”;
- Director of the Pharmacy Professional Association of Ukraine, Iryna Suvorova.
According to the pharmaceutical market participants, the draft law creates administrative barriers that may make it impossible to ensure an uninterrupted supply of medicines. They also point out that manufacturers, importers, distributors, and pharmacies that provide Ukrainians with medicines were not properly involved in the discussion of the changes.
Market participants emphasized that in the European Union, before introducing any innovations, a detailed analysis of their impact on the market is carried out and discussed with market participants.
The letter to the President emphasizes that the new regulation does not meet European standards and may negatively affect competition. Instead of transparent pricing mechanisms in place in the EU, Ukrainian legislation proposes administrative restrictions that effectively drive a number of high-quality and innovative medicines off the market. This creates a risk that patients will lose access to important medicines and international pharmaceutical companies will wind down their operations in Ukraine.
In particular, industry experts predict that the new regulation may result in problems with the supply of vital medicines, especially those not produced in Ukraine. They also warn that strict regulation of the pharmaceutical market could lead to shortages of medicines, an increase in their cost, and the development of a shadow market.
"The Law of Ukraine, which requires pricing based on the price of medicines in a number of reference countries that have not yet been determined, without taking into account the degree of reimbursement of medicines at public expense, which is a common practice in EU member states, will make it impossible to access, in particular, original medicines and medicines with proven bioequivalence that meet the standards of evidence-based medicine and modern recommendations of leading medical communities. This will not only threaten patients with the lack of treatment of appropriate quality, but will also lead to negative results for business companies whose portfolios contain mostly innovative medicines; the threat of significant business losses and reduced accessibility also applies to manufacturers with more diversified portfolios of medical products," the letter says.
Market participants also point out that the proposed changes in the regulation of the pharmaceutical market will reduce the availability of medicines for patients.
"Restricting access to the drug market by price parameters and limiting market relations in the drug distribution system will not lead to lower drug prices, but will reduce their physical availability to patients across the country. The main consequence of such actions will be a systemic crisis in the healthcare sector due to the actual disruption of the logistics chain of the established system of providing medicines to the population, shortages of medicines, which will automatically lead to a decrease in both physical and economic availability of medicines, deterioration of public health, social tension, and growth of the shadow market," market participants noted.
Currently, drug manufacturers are implementing social and humanitarian projects in the healthcare sector, investing in clinical trials, and supporting Ukrainian patients with special initiatives aimed at reducing the cost of certain categories of drugs in the absence of state funding, but the restrictions imposed may force them to reconsider the decision to continue such support, the letter says.
According to the signatories, in order to really reduce the cost of medicines, it is necessary to expand the reimbursement program "Affordable Medicines" within the framework of state guarantees of medical care for the population. An important step is the further development of the reimbursement scheme with the definition of medicines subject to reimbursement based on the assessment of medical technologies and priority therapeutic areas. They also consider it expedient to continue using the mechanism of managed access agreements, which will optimize the pricing of medicines while maintaining the confidentiality of price agreements.
Given the criticality of the situation and the significant risks of destabilization and reduced access to medicines for patients, we urge you to intervene in the current situation and veto the Law of Ukraine, returning it to the Verkhovna Rada of Ukraine for lawmakers to develop proposals for clear safeguards to avoid potential shortages of medicines
The pharmaceutical market participants also emphasized the need for an open dialogue on updating the rules for regulating their activities.
Recall
The Verkhovna Rada passed in the second reading the draft law No. 11493 on the regulation of the pharmaceutical market. In particular, one of the provisions is the establishment of a margin of 8% for distributors and representative offices of foreign pharmaceutical companies.
The European Business Association called on the President of Ukraine to veto the draft law passed by the parliament due to concerns that the innovations could negatively affect the health of patients. Concerns were also expressed by member companies of the American Chamber of Commerce, which also called on the President to veto the law.
Add
Health Minister Viktor Lyashko has not ruled out a possible reduction in the range of medicines in pharmacies after the law comes into force, which could affect the availability of medicines for Ukrainians.
Inna Ivanenko, Executive Director of the CF "Patients of Ukraine", in an interview with UNN, noted that the new state regulation of the pharmaceutical market could create bureaucratic obstacles for manufacturers and complicate patients' access to medicines. The restrictions could lead to supply disruptions, shortages, and price increases.