Dmytro Shymkiv, the chairman of the Darnitsa Group board of directors, has reiterated that Covid-19 pandemic has given new opportunities to Ukrainian pharmaceutics. Under the circumstances the medicines may have a simpler access to the European market. The government has to take necessary measures to make this a reality.
Not only did the Ukrainian pharmaceutical companies manage to resist the crisis trends caused by the pandemic, but they also ensured a positive dynamics of business development. The products of such leaders of the Ukrainian pharmaceutical market as Darnitsa, Farmak and Arterium were exported to 50 countries in 2020. According to the directory “Pharmaceutics of Ukraine”, last year export of products only to Kazakhstan, Azerbaijan and Uzbekistan together was worth $110 million.
It’s a well-known fact that the European Union needs medical supplies from abroad. However, the problem is that Ukrainian products cannot get there, since the GMP (Good Manufacturing Practice) certificates issued here are not recognized.
Shymkiv notes that both the medicines produced in Ukraine and the production facilities meet the requirements set out for them in the European Union. Hence, they can very well meet the needs of European customers. However, in order to sell products in Europe, companies are forced to undergo GMP certification within the framework of European procedures.
The question is to what extent Ukrainian pharmacological enterprises are ready to fulfill the requirements stipulated by the EU legislation in relation to GMP standards. European legislation is characterized by a very scrupulous interpretation of international GMP standards. Such a strict approach to manufacturers is due to the fact that high safety standards for consumers, including patients are of the utmost importance in this region.
There is a way out of the legal conflict described above: Ukraine should simply sign an ACAA agreement with the EU (Agreement on Conformity Assessment and Acceptance of Industrial Products). This legal document has received the colloquial name “industrial visa-free entry”. As noted by Dmytro Shymkiv, the subject of the said agreement can only be the goods mentioned in Annex III of the Association Agreement between Ukraine and the EU. The problem is that medications are not currently on this list.
Consequently, the entry of Ukrainian medicines into the European market directly depends on the prompt actions of the state authorities of Ukraine, which are entrusted with the task of revising the terms of the Association Agreement.
As Sergii Bobyliov, director for regulatory and legal relations at Darnitsa, noted, international law provides for an algorithm in such situations when it becomes necessary to expand the scope of agreements, including appendices to them. This mechanism is quite applicable to Annex III, i.e. future ACAA agreement. The key to solving the problem lies in Brussels, and the outcome of the case depends on whether the EU is ready to help Ukraine in this matter. In turn, Ukraine should make every effort and find such arguments so that Brussels sees its interest in expanding “industrial visa-free entry”, since it will benefit patients from EU countries. This goal can be achieved by coordinating actions of the Cabinet of Ministers, the Ministry of Economy, the Ministry of Health, aimed at lobbying this issue in the EU institutions.
Reflecting on this issue, the chairman of the Darnitsa Group board of directors Dmytro Shymkiv also noted that Ukraine is quite capable of selling more goods with high added value abroad, thus expanding its presence in the EU, because Ukrainian pharmaceutical companies have both the necessary capacities and products of proper quality. Now the state should come into play, as it is to prepare and sign agreements with the European Union that would allow Ukrainian-made medicines gain access to the European market, which is of key importance for Ukraine.
The situation Ukraine is in, in fact, is far from unique, because in the past similar approaches have already been used to solve this problem by signing bilateral agreements on mutual recognition (Mutual Recognition Agreements, MRA). For example, the European Union has entered into such agreements with a number of countries that have implemented a strict system of supervision over the circulation of medicines, which indicates a high level of trust to these countries. In particular, we are talking about agreements with countries such as Australia (1999), Canada (2003), Israel (2013), Japan (2004), New Zealand (1999), Switzerland (2002) and the USA (2017/2019). Presence of such agreements greatly facilitates the process of importing products, since the parties trust each other’s GMP inspection systems. In order to carry out operations, it is enough to provide information on quality checks and deficiencies, and there is no need to test each batch of imported products.