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Expert: Patients have no access to affordable pharmaceuticals because of Ukrainian patent legislation

The current regulations slow down the market.

Expert: Patients have no access to affordable pharmaceuticals because of Ukrainian patent legislation
Photo: apteka.ua

Patients in Ukraine have limited access to affordable and effective medications due to the current Ukrainian intellectual property protection law, Svitlana Didenko, a member of the PrJSC Pharmaceutical firm Darnitsa supervisory board, said in an interview with apteka.ua website. 

She blamed the ineffective regulation of the production of generics, the authorized copies of original medications.

"Any kind of research and registration of generics medication in Ukraine is forbidden until the validity of an original pharmaceutical patent expires. In the meantime, generics companies across the globe start producing generic copies while a patent is still valid. This is a normal practice that speeds up the generics market launch. As a result, patients get faster access to high-quality and affordable medications," Didenko explained.

Didenko said that Ukraine’s legislation in this sector was already harmonized with the European Union standards but some important differences still remain.

"This is why market players have been waiting for important amendments to be made to the Ukrainian regulatory system as soon as possible… Meanwhile, national producers have no opportunity to compete with European generics companies on equal terms. As a result, Ukrainian patients have poor access to affordable and effective medications," she added.

Didenko also recalled that the majority of pharmaceuticals in Ukraine are generics as this type of medication is cheaper than the original pharmaceuticals and thus is more affordable for the population.

As reported, the so-called patent cliff is coming in the world’s pharmaceutical business. Patent validities of the so-called blockbuster medication of more than $1bn sales volume per year are coming to an end. Ukrainian producers will get generics production opportunities.

Full correspondence to the quality, safety and effectiveness of original medications is a mandatory condition to generic pharmaceuticals.

All generics pass special bioequivalence tests for confirmation of medication replaceability.

The PrJSC Pharmaceutical firm Darnitsa was founded in 1930. It is a leading Ukrainian pharmaceutical production company in terms of volume. The company’s portfolio includes more than 250 names of pharmaceutical products. In 2017, the company earned 2.530bn hryvnyas from sales, which is 19% more than in 2016.

The company’s net profit in 2017 was 342.111m hryvnyas. The Zagoriys family, including Hlib Zagoriy, a lawmaker of the 8th convocation of the Ukrainian parliament, is the ultimate beneficiary of the PrJSC Pharmaceutical firm Darnitsa.

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