<\/p>\n
The European Business Association welcomes the Government\u2019s initiative to expand the \u201cAffordable Medicines\u201d reimbursement programme by adding new International Nonproprietary Names (INNs). At the same time, member companies are seriously concerned about the proposed changes to the reimbursement mechanism for medicinal products set out in the draft Cabinet of Ministers Resolution. In particular, certain provisions of the document appear to discriminate against market participants based on the origin of products, which could undermine fair competition and limit patients\u2019 access to treatment.<\/p>\n
Firstly, the business community draws attention to provisions that would directly restrict the participation of a significant number of foreign-manufactured medicines in the \u201cAffordable Medicines\u201d programme across several INNs<\/strong>. These medicines have long been present on the Ukrainian market, are widely used by patients, and ensure stable treatment outcomes. In the Association\u2019s view, the proposed mechanism effectively creates advantages for manufacturers based on the origin of their products rather than on clinical and economic effectiveness criteria.<\/p>\n Ukraine has introduced a health technology assessment (HTA) system, which enables recommendations regarding the clinical and economic benefits of treatment with particular medicinal products. These findings serve as the basis for public funding decisions regarding medicines, including for reimbursement purposes. Therefore, disregarding these criteria \u2014 widely recognised as the \u201cgold standard\u201d for decision-making in healthcare management \u2014 raises concerns.<\/p>\n Secondly, some of the INNs included in the proposed list are not part of the National List of Essential Medicines and are also absent from the WHO Model List of Essential Medicines<\/strong>. In the opinion of the business community, this creates risks of moving away from transparent and predictable approaches to shaping state policy in the field of pharmaceutical provision and may strengthen elements of discretionary management within the system.<\/p>\n It is important to emphasise that support for domestic manufacturers is applied in many EU and WTO member states. Such instruments may include tax incentives, grant programmes, or investment support measures. However, European countries approach the implementation of such mechanisms in a balanced manner. International practice does not provide for excluding other manufacturers from participation in nationwide reimbursement or public financing programmes based on the country of origin of their products. Sector-specific considerations are also taken into account, particularly given that this issue directly concerns restrictions on patients\u2019 freedom to choose medicinal products. Therefore, the Association stresses that the proposed approaches may create risks of non-compliance with certain international obligations undertaken by Ukraine in the areas of international trade and competition.<\/strong><\/p>\n No less significant are the risks related to supply volumes and ensuring patients\u2019 needs for medicines. At present, there is no publicly available information regarding calculations of the full patient demand for the relevant INNs, assessments of manufacturers\u2019 production capacities to cover such demand, or mechanisms for rapid response in the event of supply disruptions in order to replenish stocks with medicines from other manufacturers.<\/strong><\/p>\n Restricting participation in the reimbursement programme to only certain manufacturers may create real risks of medicine shortages and interruptions in patient treatment. Other pharmaceutical manufacturers may also reconsider their supply volumes to Ukraine due to the inability to market their products under equal conditions with other market participants.<\/strong> Therefore, rapid supply to address shortages is unlikely to be feasible without advance planning. At the same time, the issues of bioequivalence and interchangeability of medicinal products in Ukraine still require comprehensive regulation, which would, in turn, help strengthen trust among patients and the medical community.<\/p>\n In conclusion, the Association believes that decisions in the field of patient treatment should primarily be based on the principles of clinical and economic effectiveness, continuity of access to therapy<\/strong>, predictability of supply, and patients\u2019 interests<\/strong>, rather than solely on the origin of products.<\/p>\n In this regard, the business community calls on the Ministry of Health of Ukraine and the Government to:<\/p>\n <\/p>","protected":false},"excerpt":{"rendered":" The European Business Association welcomes the Government\u2019s initiative to expand the \u201cAffordable Medicines\u201d reimbursement programme by adding new International Nonproprietary Names (INNs). At the same time, member companies are seriously concerned about the proposed changes to the reimbursement mechanism for medicinal products set out in the draft Cabinet of Ministers Resolution. In particular, certain provisions […]<\/p>\n","protected":false},"author":33544,"featured_media":742951,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false},"categories":[4,5,22],"tags":[],"yoast_head":"\n\n