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Dmytro Shymkiv: Ukrainian drugs should receive «industrial visa-free» access to European markets

The Ukrainian pharmaceutical industry received a unique chance to simplify access for drugs to the European market amid the COVID-19 pandemic, but this requires appropriate steps from the authorities, as Dmytro Shymkiv, the Chairman of Darnitsa Directors’ Service, has repeatedly said.

The Ukrainian pharmaceutical industry was able to overcome the negative effects of the pandemic and even show growth, with drugs produced by Ukrainian companies, including Darnitsa, Farmak and Arterium, being exported to 50 countries in 2020. According to the Pharmaceutics of Ukraine Guide, exports to Kazakhstan, Azerbaijan and Uzbekistan alone reached $110 million last year.

But in the European Union, which usually depends on supply of drugs from abroad, Ukrainian products are almost absent due to non-recognition of GMP (Good Manufacturing Practice) certificates issued in Ukraine, according to the authors of the article.

Shymkiv assures that the quality of Ukrainian drugs as well as their production capacity fully meets the requirements of EU countries and can meet the needs of European patients, but in order to sell them in the EU, they have to go through the European procedures of GMP certification again.

First of all, it is about readiness of Ukrainian pharmaceutical companies to meet the requirements of EU legislation to comply with GMP standards. The European legislation interprets international GMP standards in the most scrupulous way that corresponds to the general sense of high consumer safety standards, and in this case patient safety.

To overcome the legal barrier, Ukraine needs to sign an agreement ASAA (Agreement on Conformity Assessment and Acceptance of Industrial Products) with the EU – the so-called industrial visa-free regime specifically for drugs. According to Dmytro Shymkiv, such an agreement can only be concluded for the goods from the list of Annex III of the Association Agreement between Ukraine and the EU, but drugs have not been listed there yet.

Therefore, the publication says that how soon Ukrainian drugs will be available on the European market depends on the public authorities involved in the revision of the Association Agreement.

“The algorithm to expand the scope of Annex III, in other words, extend the scope of the future ASAA agreement, is quite clear from an international legal perspective. Now the thing depends on the political will of the EU to do Ukraine a favour. We have to convince Brussels that extension of the industrial visa-free regime for drugs from Ukraine is in the interest of Europe, European medicine manufacturers and, ultimately, European patients”, Serhii Bobylev, Director for regulatory and legal affairs of Darnitsa, emphasized. “The Ukrainian pharmaceutical sector has to join forces with the Cabinet of Ministers, Ministry of Economy and Ministry of Public Health in a big effort to lobby the EU institutions to do this”.

“We can expand exports of goods with high added value and expand our presence in the EU. The Ukrainian ‘pharma’ is ready for this, both in terms of available capacity and product quality,” Dmytro Shymkiv, the Chairman of the Board of Directors of Darnitsa Group, added. “The next step is up to the authorities. Our government has to do its great homework, prepare and sign agreements with the European Union, which will open wide access for Ukrainian drugs to this key market”.

There are cases in European practice to solve this problem by concluding bilateral mutual recognition agreements (MRAs). To this date the EU has concluded seven agreements already: with Australia (1999), Canada (2003), Israel (2013), Japan (2004), New Zealand (1999), Switzerland (2002) and the USA (2017/2019), namely with countries where the drugs surveillance system has a high level of trust on its part. These documents allow parties to rely on each other’s GMP inspection system, exchange information on quality inspections and deficiencies, and waive testing of imported products batches.

Published 01.12.2021 16:52

Source - Ereport.ru

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