The Norwegian Medicines Agency led the project group, which consisted of representatives from all five Nordic countries
Small markets
The Nordic countries are small markets with few patients and are relatively unattractive to pharmaceutical companies. As a result, many EU-approved medicines aimed at children are not readily available in the Nordic countries because they are not marketed here or are withdrawn from the market. Low profitability and low sales volumes are confirmed as the main reasons in the companies' responses to the Norwegian Medicines Agency's questionnaire.
The greatest problems with regard to availability concern medicines which are aimed at the very youngest children. Healthcare professionals must therefore strive to obtain paediatric formulations through exemption from approval from abroad, or find ways of administering the medicine in the correct paediatric dosage. Medicines are often used outside their approved area of use, and healthcare professionals must have a sound knowledge and be very careful to avoid medication errors.
“We are often asked why an EU-approved medicines is on the market in Germany or another Nordic country, but not in Norway. We cannot force a company to supply the Norwegian market. With this project, we therefore decided to look at what we as a regulatory authority can do to get more paediatric medicines to the entire Nordic region,” says Medical Director Siri Wang.
Nordic co-operation with a common strategy
The project group agreed that, although the Nordic countries use different instruments to both retain and get new sought-after medicines on the market, the measures do not appear to be sufficiently effective.
We want to see Nordic co-operation regarding paediatric medicines. There are a number of areas where we could have practical cooperation, for example by identifying common needs for medicines, cooperating with regard to approval processes, and assessing common incentives that could be of relevance to the industry. Perhaps the Nordic region could constitute a common market with a common strategy?” asks Wang.
Challenges and differences
The regulatory system and procedures for medicinal products within the EU/EEA are complex. Collaboration across established structures cannot be implemented without facilitation.
“We have identified a number of opportunities in our report. How closer Nordic co-operation should be further developed must be considered in more detail,” says Wang .
Although the Nordic countries are characterised as “small markets”, there are also certain differences which mean that cooperation in some areas must be left to other networks. For example, not all the Nordic medicines regulatory authorities are responsible for pricing and the assessment of public funding.
Digital package leaflets and common Nordic packaging
Caregivers for sick children are typically young adults with a high level of digital literacy and a good knowledge of English. In addition, many medicines are administered to children in a secure environment in hospitals by healthcare professionals who rarely refer to the paper version of the package leaflet.
The current requirement to produce national pharmaceutical packages with a paper package leaflet is costly for pharmaceutical manufacturers. The European Commission's proposal for new legislation on medicinal products gives national authorities the scope to grant exemptions. It is a goal that countries with small markets can join forces and use common packaging and digital package leaflets. This could help improve the availability of medicines to small groups of patients, such as paediatric drugs.
About the project:
The aim of the project was to assess the possibility of closer cooperation in order to increase the number of approved paediatric medicines being marketed in the Nordic countries. The Norwegian Medicines Agency was tasked by the Ministry of Health and Care Services with leading the project, which was funded by the Nordic Council of Ministers. The project group was led by Medical Director Siri Wang, who is also the Norwegian Medicines Agency's representative on the EMA's Paediatric Committee (PDCO).
Contacts were established with the authorities in all five Nordic countries for paediatric medicines, and a survey conducted to map out how the authorities currently facilitate the availability of important medicines in small markets. A workshop was held in Oslo in the autumn of 2022.
In its report, the project group identified a number of opportunities for collaboration:
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Information exchange in approval procedures
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Shared use of instruments and incentives with regard to the industry
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Consider a common list of paediatric medicines that are needed
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Closer dialogue regarding common Nordic packaging and exemptions from the requirements for product information in national languages