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Discrimination against international pharmaceutical manufacturers and lack of medicines quality assurance are unacceptable

13/ 04/ 2020
  The EBA experts warn that postal deliveries of medicines by manufacturers to pharmacy chains during the quarantine period are non-transparent regulation that discriminates against international manufacturers and does not guarantee the quality of the product. Amidst the chaos in the country at the beginning of the quarantine, which was introduced by the state to slow down the COVID-19 epidemic, unfortunately, there emerged opportunities for non-transparent and unscrupulous regulation in favor of some pharmaceutical businesses. In March 2020, 2 draft amendments to the same CMU Resolution - on Licensing Terms and Conditions for Pharmaceutical Companies - were submitted for public discussion. At the same time, one of the drafts was submitted for discussion on the website of the Ministry for Development of Economy, Trade and Agriculture on March 20, 2020, and the other - on the website of the Ministry of Health of Ukraine on March 24, 2020. The latter was recently unveiled to the public as already approved by the CMU Resolution. However, as it turned out, CMU Resolution №220 was dated March 23, 2020 – which means there was no public discussion. According to the EBA, in addition to the lack of transparency, the new regulation also violates the principle of equal competition conditions for all market players. As a result of the approved CMU Resolution, only some players, namely Ukrainian drug makers, received preferences. Moreover, according to the text of the amendment, the quality of the supplied medicines is not guaranteed. Thus, under the new quarantine regulation, manufacturers are permitted to use mailing facilities to deliver drugs to pharmacies. However, only Ukrainian manufacturers with production licenses had such possibilities. The new regulation deprived wholesale distributors and international manufacturers that supply medicines with an import license of similar work conditions. This demonstrates the discriminatory approach of the authorities to international pharmaceutical manufacturers that supply effective, high-quality and safe medicines to Ukraine. Unfortunately, over the last year, it was not the first time for the international pharmaceutical community to be discriminated against. Representatives of international manufacturers have repeatedly witnessed attempts to create barriers to their activity in the Ukrainian market. This concerns the Draft Law on Medicines considered by the Ministry of Health of Ukraine last autumn, the draft Concept for the Development of the Pharmaceutical Industry, as well as three versions of the draft amendments to the GMP certification procedure in Ukraine. Obviously, existing barriers for international pharmaceutical manufacturers deprive the Ukrainian population of the necessary medicines. Only with an unbiased approach to all market participants, the state can create the necessary conditions to build trust with international partners, attract investment and innovative technologies that Ukraine needs. As a result, this approach would contribute to the development of Ukrainian business both domestically and abroad. Instead, overt pro-Ukrainian preferences only negatively affect the countrys investment attractiveness and, at the same time, do not stimulate its progress in negotiations with intergovernmental organizations and business partners in other areas of economic relations. Also, the content of the new regulation regarding the quality assurance of medicines, delivered by post from manufacturers to pharmacies, is questionable. Unfortunately, the text of the implemented CMU Resolution does not contain any provisions that would ensure proper storage and transportation of manufactured medicines by postal operators. The Association urges the Government of Ukraine to refrain from the establishment of any unequal conditions in the pharmaceutical market both during the quarantine period and beyond. Also, we ask not to put the quality of the medicines for patients under risk. Thus, the current situation should be fixed and the CMU Resolution №220 of 23.03.2020 should be repealed as one that was adopted in a non-transparent, impractical and risky manner for the health of the population of Ukraine.  

The EBA experts warn that postal deliveries of medicines by manufacturers to pharmacy chains during the quarantine period are non-transparent regulation that discriminates against international manufacturers and does not guarantee the quality of the product.

Amidst the chaos in the country at the beginning of the quarantine, which was introduced by the state to slow down the COVID-19 epidemic, unfortunately, there emerged opportunities for non-transparent and unscrupulous regulation in favor of some pharmaceutical businesses.

In March 2020, 2 draft amendments to the same CMU Resolution – on Licensing Terms and Conditions for Pharmaceutical Companies – were submitted for public discussion. At the same time, one of the drafts was submitted for discussion on the website of the Ministry for Development of Economy, Trade and Agriculture on March 20, 2020, and the other – on the website of the Ministry of Health of Ukraine on March 24, 2020. The latter was recently unveiled to the public as already approved by the CMU Resolution. However, as it turned out, CMU Resolution №220 was dated March 23, 2020 – which means there was no public discussion.

According to the EBA, in addition to the lack of transparency, the new regulation also violates the principle of equal competition conditions for all market players. As a result of the approved CMU Resolution, only some players, namely Ukrainian drug makers, received preferences. Moreover, according to the text of the amendment, the quality of the supplied medicines is not guaranteed.

Thus, under the new quarantine regulation, manufacturers are permitted to use mailing facilities to deliver drugs to pharmacies. However, only Ukrainian manufacturers with production licenses had such possibilities. The new regulation deprived wholesale distributors and international manufacturers that supply medicines with an import license of similar work conditions. This demonstrates the discriminatory approach of the authorities to international pharmaceutical manufacturers that supply effective, high-quality and safe medicines to Ukraine.

Unfortunately, over the last year, it was not the first time for the international pharmaceutical community to be discriminated against. Representatives of international manufacturers have repeatedly witnessed attempts to create barriers to their activity in the Ukrainian market. This concerns the Draft Law on Medicines considered by the Ministry of Health of Ukraine last autumn, the draft Concept for the Development of the Pharmaceutical Industry, as well as three versions of the draft amendments to the GMP certification procedure in Ukraine. Obviously, existing barriers for international pharmaceutical manufacturers deprive the Ukrainian population of the necessary medicines.

Only with an unbiased approach to all market participants, the state can create the necessary conditions to build trust with international partners, attract investment and innovative technologies that Ukraine needs. As a result, this approach would contribute to the development of Ukrainian business both domestically and abroad. Instead, overt pro-Ukrainian preferences only negatively affect the country’s investment attractiveness and, at the same time, do not stimulate its progress in negotiations with intergovernmental organizations and business partners in other areas of economic relations.

Also, the content of the new regulation regarding the quality assurance of medicines, delivered by post from manufacturers to pharmacies, is questionable. Unfortunately, the text of the implemented CMU Resolution does not contain any provisions that would ensure proper storage and transportation of manufactured medicines by postal operators.

The Association urges the Government of Ukraine to refrain from the establishment of any unequal conditions in the pharmaceutical market both during the quarantine period and beyond. Also, we ask not to put the quality of the medicines for patients under risk. Thus, the current situation should be fixed and the CMU Resolution №220 of 23.03.2020 should be repealed as one that was adopted in a non-transparent, impractical and risky manner for the health of the population of Ukraine.

 

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