{"id":789506,"date":"2025-05-26T14:18:07","date_gmt":"2025-05-26T11:18:07","guid":{"rendered":""},"modified":"2025-05-26T21:14:03","modified_gmt":"2025-05-26T18:14:03","slug":"biznes-zaklykaye-utrymatys-vid-suttyevoyi-zminy-litsenzijnyh-umov-na-farmatsevtychnomu-rynku","status":"publish","type":"post","link":"https:\/\/new.eba.com.ua\/en\/biznes-zaklykaye-utrymatys-vid-suttyevoyi-zminy-litsenzijnyh-umov-na-farmatsevtychnomu-rynku\/","title":{"rendered":"Business urges against major changes to licensing conditions in the pharmaceutical market"},"content":{"rendered":"

In April, the State Service of Ukraine on Medicines and Drugs Control published a draft resolution of the Cabinet of Ministers of Ukraine<\/a> proposing significant amendments to the Licensing Conditions for carrying out business activities related to the manufacturing, wholesale, and retail trade, and import of medicinal products (excluding active pharmaceutical ingredients).<\/p>\n

After analysing the proposed changes, experts from the European Business Association noted that some of the provisions \u2013 in particular clause 31-3 \u2013 would effectively introduce a new model for regulating contractual and commercial relationships between manufacturers\/importers of medicinal products and business entities.<\/p>\n

Under these rules, manufacturers and importers would be forced to limit the volume of product sold to any single company. For instance, if a pharmacy or distributor purchased more than 20% of a certain product over the previous year, they would no longer be able to buy more without additional conditions \u2013 even if other market participants show no interest. In such cases, manufacturers would be required to artificially restrict sales.<\/p>\n

Manufacturers would also be obliged to disclose and publish internal rules for working with clients \u2013 including how to submit orders, deadlines, and formats. All of this would need to be formalised and made public, even if it involves commercially sensitive information.<\/p>\n

Control over adherence to these rules would lie with the State Service. However, it is crucial to understand that, by law, the State Service is mandated to oversee only the technical aspects of business operations \u2013 such as equipment, personnel, and quality control. Granting it powers to oversee commercial terms of contracts and limit sales volumes represents an unlawful expansion of regulatory authority<\/strong>.<\/p>\n

Business representatives believe that matters such as defining “equality of conditions”, “equivalence of transactions”, evaluating discounts and other economic indicators also fall under the jurisdiction of the Antimonopoly Committee of Ukraine (AMCU), leading to overlapping regulation.<\/p>\n

As a result, a single violation could lead to double penalties \u2013 the AMCU may impose a fine for breaching competition law, while the State Service may revoke a licence for violating licensing conditions. This constitutes a disproportionately severe sanction<\/strong> and creates excessive risk for businesses.<\/p>\n

Consequently, instead of operating under fair competition, manufacturers and importers would face restrictions on supplying medicines to those who actually need them \u2013 and risk sanctions even when market demand is objectively low.<\/p>\n

Such a move could result in supply disruptions and negatively affect patients\u2019 access to medicines. The market would become less predictable and less attractive to investors and manufacturers.<\/p>\n

For these reasons, business representatives do not support the proposed addition of clause 31-3 to the Licensing Conditions, as outlined in the draft resolution.<\/p>\n

The EBA formally communicated its position in an official letter and presented it during stakeholder discussions. This position was consolidated and supported by the majority of sectoral associations representing around 95% of foreign companies and key players in Ukraine\u2019s pharmaceutical sector.<\/p>\n

Despite this, the industry\u2019s feedback was not taken into account during the public consultation. Therefore, the EBA calls for a re-evaluation of the proposed clause and urges authorities to refrain from including clause 31-3 in the Licensing Conditions. Regulatory changes must be implemented transparently, predictably, and with due regard for balancing the interests of the state, business, and patients.<\/p>\n","protected":false},"excerpt":{"rendered":"

In April, the State Service of Ukraine on Medicines and Drugs Control published a draft resolution of the Cabinet of Ministers of Ukraine proposing significant amendments to the Licensing Conditions for carrying out business activities related to the manufacturing, wholesale, and retail trade, and import of medicinal products (excluding active pharmaceutical ingredients). After analysing the […]<\/p>\n","protected":false},"author":33544,"featured_media":645210,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[15564,15563,15574],"tags":[],"class_list":["post-789506","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-lobbying-news-en","category-main-news-en","category-news-and-articles-from-association-en"],"_links":{"self":[{"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/posts\/789506","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/users\/33544"}],"replies":[{"embeddable":true,"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/comments?post=789506"}],"version-history":[{"count":0,"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/posts\/789506\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/media\/645210"}],"wp:attachment":[{"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/media?parent=789506"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/categories?post=789506"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/tags?post=789506"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}