Where next? Geographic expansion: the regulatory perspective. Part 2: the Baltics
SummaryPart two of a four part series
In a new blog series, Kimty Bui-Van of ProductLife Group considers how increasing regulatory harmony between regions is improving the prospects for companies looking to grow their global opportunity
Evaluating the Baltic region
Since joining the European Union, Lithuania, Latvia, and Estonia have adopted relevant European Union legislation; and companies preparing local submissions must have authorisation from the local authority (each country has its own) or from the European Medicines Agency (EMA) depending on the type of registration. The respective national authorities cooperate readily, and they liaise closely with EMA, the European Directorate for the Quality of Medicines & HealthCare, and other international organisations. In Latvia, the State Agency of Medicines assesses medicines before issuing market authorisations. Estonia also has a State Agency of Medicines. Lithuania’s regulatory body is called the State Medicines Control Agency.
With a combined population of around 6.3 million—2.9 million in Lithuania, 2 million in Latvia, and 1.3 million in Estonia—the Baltic region is not known as a significant producer of pharmaceuticals. Of the three countries, Latvia has the strongest pharmaceutical industry, with production estimated at €120 million, but the region has a long way to go to catch up to other European markets
.Opportunities & challenges
EU legislation requires that a marketing authorisation holder reside in the European Union. None of the Baltic countries requires the presence of a regulatory person, nor must there be a native speaker within each country to work with authorities; and authorities tend to communicate in English. It is advisable to have a native speaker for translations of summaries of product characteristics and packaging materials, however, and to provide advice on product implementation.
When a company receives approval for a new variation, the product must be implemented within one year, so having someone in country to monitor the environment and provide information about changes can be invaluable. The Baltic region has seen a marked decline in mortality rates in the past 15 years, yet the rates remain high compared with many other European countries. For instance, Latvia’s premature death rate per 100,000 people is 400 compared with Spain’s 142. That presents particular health-care challenges. But all three countries have recorded pharmaceutical market growth, with promising potential for innovative life sciences companies. In Estonia, improved reference pricing systems have led to a shift in spending—from older medicines to more-expensive innovative medicines.
Unlike more-complex European markets, the Baltics are relatively easy to manage from a distance. Their regulatory authorities are easy to communicate with and open to discussion. Dossier submission can be managed electronically via the Common European Submission Portal (or Platform) (CESP), though for Latvia, a signed paper application form, a cover letter, and proof of payment are required via courier or post in parallel with the CESP submission. The relative underdevelopment of the market and considerable potential and appetite for innovation make the Baltics an attractive strategic target for international expansion.
In the next blog, Kimty Bui-Van looks at current regulatory conditions and market growth prospects for life sciences in South Africa.
Kimty Bui-Van is head of regulatory affairs and pharmaceutical services at ProductLife Group.