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published on 11 November 2020 | Reading time approx. 5 minutes
Every company, with no exception, actively seeks for suitable, profitable, cost and time efficient solutions for conducting business. Pharmaceutical companies respectively desire in particular to place their medicines on all business wise potential markets with less effort and expense. We will provide you hereby with an insight of the Baltic pharmaceutical market and an overview of most advantageous options for further business.
Where a medicine is registered under the centralised authorization procedure with the European Medicines Agency (EMA), it may be sold in all European Union countries. However, as the procedure is very complex, expensive and rather long, pharmaceutical companies often take advantage of decentralized procedures and request authorization or registration of their products only in few or sometimes only in one country for analysing and efficiency purposes. Should the product have any success, the pharmaceutical companies or marketing authorization holders tend to place the products on other markets, while taking into account respective conditions assisting to minimize cost and registration time required.
There are a number of options for placing medicinal products onto the respective market. Should the medicine be new, less popular and less widely spread, we would suggest to follow the procedure for so called “named-patient basis” treatments, which see doctors obtain medicines directly from manufacturers before authorisation. This is done on an individual basis under the direct responsibility of the doctor. The procedure especially in Lithuania is quite favourable and pharmaceutical business oriented. Although admittedly this approach requires a certain administrative interaction (e.g. the product should be acknowledged as “essential” product by the Ministry of Health or particular health institution; the wholesaler must hold an authorization for distribution of unregistered medicinal products). Nevertheless, as said, this procedure is in certain cases advantageous, as we will see in the following.
To the contrary to Estonia and in certain cases to Latvia, Lithuanian pharmaceutical companies are allowed to contact the medical doctors and health care institutions directly in order to explain and advocate for the benefits and advantages of their products without interference of any authority or other intermediary. Accordingly, the medical doctor having all necessary information on the product may prescribe the respective medicine to an individual patient. Whereas pharmacies refer to the distributors directly for the order of such medicines having no intermediaries.
Similar to Lithuania, the medical doctors and health care institutions may decide at their discretion on the most beneficial and suitable medicine for a patient in the individual case. However, the distributor should apply for importing licence as soon as the request for use of the respective medicinal product has been received. The importing licence is issued by the State Agency of Medicines. The procedure takes 3 - 7 days. However, it may be prolonged up to 4 months depending on the compliance of documentation with national requirements and the type of product. For each import of a medicinal product intended for “named-patient basis” treatment, a separate licence must be obtained. As the national competent authority is involved, the procedure takes a little longer compared to Lithuania and requires additional financial and time efforts. On the other hand it should be noted that the physicians and healthcare institutions play an essential role in prescribing a specific medicinal product.
Regulations and requirements differ in Estonia significantly. Therefore, unfortunately, Estonia is the least attractive Baltic country for marketing a medicinal product as intended for “named-patient basis” treatment. Should the active substance be listed in the list of active substances for non-authorized medicinal products, the wholesaler must apply for import license at least 5 days prior to importing. No import quantity limits apply. The procedure takes approx. 7 – 14 days. In other cases (where the substance is not listed) the approval of the State Agency of Medicines is required. Accordingly, the medical doctor or healthcare institution must provide the authority with the prescription and respective application form. As soon as the permission for use has been granted, the wholesaler may apply for the import license. The administrative procedure takes ca. 1 – 2 months. Considering that the Estonian Agency of Medicine is significantly involved in the distribution and wholesale of medicinal products in general and specifically those intended for “named-patient basis” treatment, and taking into account the complexity of the procedure and expense it may require, it is probably advisable to aim at including the substance concerned into the list of active substances for non-authorized medicinal products.
Pharmaceutical companies, in particular the manufacturers, market many of their drugs both in the Baltic States and in other EU or EEA Member States and have a separate national marketing authorization for each of these in the respective Member State. Third, of the original marketing authorization owner and/or manufacturer independent companies, can rely on the possibility of the parallel import, if they acquire such medicinal products in another EU and/or EWR Member State and import it into one or more of the Baltic States, in order to place them there - parallel to the original pharmaceutical entrepreneur - likewise on the market. However, this presupposes that these third party companies submit an application for a marketing authorization for the parallel import to the competent national authority, even if, on the basis of the case law of the European Court of Justice, a simplified marketing authorization procedure applies in which the parallel importer shall submit only a small part of the legally required documents. The national authority performs a primary expert-examination of the submitted information within five working days and verifies the conformity to the national and EU regulations. The national competent authority contacts and communicates with the authority of the respective product registration state. The procedure should take around 30 days; although it usually takes longer as the correspondence between the authorities on the information completeness and other additional actions often cause delays.
Should the marketing as medicinal products intended for “named-patient basis” treatment and the parallel import not be possible or adequate in individual cases, pharmaceutical companies may opt for the procedure of mutual recognition. Obviously this requires that the medicinal product concerned has already been authorized in at least one other EU Member State (reference state). This approval can then be recognized in one or all Baltic States. To this end, it is necessary for the applicant to update the documentation underlying the existing national authorization with the competent authority of the reference state so that an assessment report can be drawn up. The assessment report shall be prepared within 90 days of receipt of the updated marketing authorisation dossier. After a validation phase, the actual mutual recognition procedure follows, during which the respective member state recognizes the authorization within the 90-day period. Once the authorisation has been recognised under this procedure, the applicant must submit a translation of the product literature into the language of the Member State in which the authorisation was recognised. The approval authority will issue the national approval notice within a maximum of 30 days after receipt of the correct translations. In the Baltic States, this is usually issued already after 14 days.
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Although in the Baltic States similar legal and administrative requirements to those in other EU Member States apply for the placement of medicinal products on the market, based on our experience in practice we see that there are favourable conditions in Lithuania, Latvia and Estonia, enabling pharmaceutical companies to introduce their medicinal products. Moreover, the administrative procedures are rather fast and efficient. In the following we have summarized the essential information of respective procedure available in the Baltics.
Eglė Pinaitė
Associate Partner
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Matīss Jākobsons
Lawyer assistant (Latvia)
