Dmytro Shymkiv: Ukrainian medicines should be granted an “industrial visa-free” entry to access to European markets

COVID-19 pandemic has unexpectedly provided for the Ukrainian pharmaceutical industry receiving a unique chance to simplify access of medicines to the European market, but this requires relevant steps from the authorities, Dmytro Shymkiv, the chairman of the Darnitsa Group board of directors, has reiterated.

The pharmaceutical industry in Ukraine was able to overcome the negative consequences of the pandemic and even demonstrate growth, and drugs produced by Ukrainian companies, in particular Darnitsa, Farmak and Arterium, were exported to 50 countries in 2020. According to the directory “Pharmaceutics of Ukraine”, last year the volume of exports to Kazakhstan, Azerbaijan and Uzbekistan together reached $110 million.

But in the European Union, which usually depends on the supply of medicines from abroad, Ukrainian products are almost absent because the GMP (Good Manufacturing Practice) certificates issued in Ukraine are not recognised in the EU, the authors of the article write.

Shymkiv assures that the quality of Ukrainian-made medicines, as well as production facilities, fully meet the requirements of the European Union countries and are able to satisfy the needs of European patients, but in order to sell products in the EU, GMP certification has to be performed again, this time via the European mechanism.

First of all, we are talking about Ukrainian pharmaceutical companies being ready to meet the requirements of EU legislation to comply with GMP standards. European legislation is interpreting international GMP standards most meticulously, which is in line with the general spirit of high standards for the safety of consumers, in this case patients.

To overcome the legal barrier, Ukraine needs to conclude an ACAA agreement with the EU (Agreement on Conformity Assessment and Acceptance of Industrial Products) - the so-called industrial visa-free regime regarding medicines specifically. According to Dmytro Shymkiv, such an agreement can only be concluded with respect to goods from the list of Annex III of the Association Agreement between Ukraine and the EU, but there are no medicines on this list yet.

Thus, it’s up to the state authorities involved in revising the terms of the Association Agreement to influence how soon Ukrainian medicines will be present on the European market, the publication says.

“From the international legal point of view, the algorithm for expanding the scope of Annex III, in other words - expanding the scope of the future ACAA agreement, is quite clear. The matter now depends on the political will of the EU to meet Ukraine halfway. We must convince Brussels that the extension of “industrial visa-free entry” for Ukrainian medicines is also in the interests of Europe, European drug manufacturers, and ultimately European patients,” stressed Sergii Bobyliev, the director of regulatory and legal relations at Darnitsa. ... “For this to happen, the Ukrainian pharmaceutical sector must join forces with the Cabinet of Ministers, the Ministry of Economy, and the Ministry of Health in the crucial task of lobbying the EU institutions.”

“We are able to expand the export of goods with high added value, and expand our presence in the EU. Ukrainian pharma is ready for this - both in terms of available capacities and product quality,” Dmytro Shymkiv, the chairman of the board of directors of Darnitsa Group, added. “Now it’s the turn of the state. Our state must do a lot of homework, prepare and sign agreements with the European Union, which will give Ukrainian medicines wide access to this key market.”

In Europe there have been precedents of solving this problem by concluding bilateral agreements on mutual recognition (Mutual Recognition Agreements, MRA). To date, the European Union has concluded seven agreements of that kind: with Australia (1999), Canada (2003), Israel (2013), Japan (2004), New Zealand (1999), Switzerland (2002) and the United States (2017/2019) - that is, with countries which drug surveillance system it trusts. 

These documents allow parties to rely on each other's GMP inspection system, share information about quality checks and deficiencies, and manage without batch testing of imported products.