The meeting of the Baltic States medicines agencies took place on 11th of April 2019 in Vilnius, Lithuania. Representatives of Lithuanian, Latvian and Estonian medicines agencies, both human and veterinary medicines, and Lithuanian Ministry of Health participated in the meeting. During the meeting, information and experience on the ongoing activities of the institutions were shared and relevant topics were discussed.
Overview of the Baltic Agencies of 2018-2019 was given. Participants discussed the challenges regarding the safety features, with which the Baltic States have been facing since 9th of February 2019, when the Commission Delegated Regulation (EU) 2016/161 entered into force.
The State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania presented the system for monitoring the presence of availability the medicinal products on the market and introduced to the main principles of the operation. Also the Lithuanian retail sale enterprises, which are allowed to sell certain medicinal products from 1st of January 2019 and about the availability of medicines in the rural areas, was talked about. The representative from Ministry of Health of the Republic of Lithuania presented the essential principles of the pricing of medicines in Lithuania and changes in the pricing of medicines in recent years. She explained how the rules for price markups for the wholesalers and pharmacies have change recently and spoke about the regulation of the price discounts at the supply chain. She also explained the changes in the reimbursement of pharmaceuticals and introduced the results that have been achieved, as well as challenges encountered.
Latvian State Agency of Medicines presented the two projects that use business intelligence software to visualize the medicines’ consumption data, as well as the use of the data in the decision making related to rapid alerts and remaining stocks at medicines wholesalers warehouses.
It was decided that next version of Baltic Statistics on Medicines will be published in August 2019. Lithuanian State Medicines Control Agency presented the project plan.
Estonian State Agency of Medicines gave an overview about the challenges regarding BREXIT. They also proposed to cooperate in joining the International Import and Export Auhorisation system (12ES) for import and export permits of narcotic and psychotropic substances.
The agencies, responsible for human medicinal products, discussed the implementation of the new clinical trials regulation and presented the challenges. The issues related to the reorganization of the bioethics committees’ and the management of the conflicts of interests were discussed. These issues are currently important in Latvia and Estonia. It was decided to exchange information among the Baltic agencies.
Latvian State Agency of Medicines suggested the possibility of setting up the multinational expert groups for the participation in the centralized authorisation procedures. The Agencies have agreed that such teams would be necessary and useful experience and that the solutions will be sought in order to set up the multi-national teams among the Baltic States.
Some topics were discussed in smaller groups. Discussion group for the implementation of the Compassionate use and Named patients programs was identified that Latvian and Estonian requirements in this field are similar, but, these programs have been of little interest to the applicants. It was decided that the Agencies will work closer and more actively on this issue while exchanging experiences, harmonizing procedures. To encourage the applicants participate more actively in these programs, the possibility of joint promotion activities was discussed.
The next topic discussed separately was the cooperation between the laboratories. IT service of computerised testing equipment was discussed, also the improvement of the distribution of the drug testing among the laboratories. The Agencies agreed that by 10th of May 2019, the laboratories will share the list of the TOP 100 medicines that were the most sold in 2018 amongst themselves. It has been decided to exchange the information among the Baltic States OMCLs on the suitability and validity of expensive metrological services for rare-use measuring devices before they are planned to purchase.
One more separate discussions’ topic was SPOR (Data management system for substances, products, organisations and referentials developed by European Medicines Agency). All three countries are actively involved in the project. Estonia and Latvia shared a useful experience of adapting their databases to the SPOR data step by step.
Representatives from the veterinary medicines agencies discussed about their functions and organization of the work. Common problems have been identified. It was decided to continue this discussion in the meeting that will take place this summer in Latvia.
The next Baltic meeting will take place in 2020 in Latvia.
Further information:
info@ravimiamet.ee
info@zva.gov.lv
vvkt@vvkt.lt
