The Nordic Council is the official cooperation body of the Nordic governments. Among the objectives of the Nordic Council, a recent statement by Norway, which currently holds the Presidency of the Council, stands out: “Together, we will act as a pioneering region internationally and contribute to the global community’s fulfillment of the UN sustainable development goals (SDGs). Consequently, Nordic co-operation isn’t just for our own region, but for Europe and the world.” This undoubtedly applies to the pharmaceutical sector as well, as we have a unique advantage in the form of Nordic solidarity built on shared values, similar cultures and mutual trust.

Shared interests with regard to the reform of the EU’s pharmaceutical legislation

The EU’s extensive reform of pharmaceutical legislation, which is based on the Pharmaceutical Strategy for Europe published in 2020, is now under way. The reform will establish the framework for the European regulation of pharmaceutical products for decades to come. The reform will also have a significant impact on the European pharmaceutical industry’s position in the global market.
Engaging in advocacy efforts regarding the content and interpretations of the upcoming legislation will be possible starting from late this year. The Nordic pharmaceutical industry and public authorities should join forces when regulatory proposals are circulated for comment, as this would enable them to influence future legislation in a manner that takes Nordic interests into account. The existing cooperation forums provide good opportunities for this.

Are Nordic packages being sufficiently utilised?

Over the past few years, the Nordic medicines agencies have taken significant action to promote the use of multi-country packaging, which serves as a model for similar projects in other countries. Joint guidelines and assessments promote the launch of cost-effective multi-country packaging. This, in turn, has a favourable effect on the availability of medicines.

This excellent process should be fostered and developed further. Can more opportunities for harmonisation be identified with regard to the views on package labelling held in different countries? Could Finland and Sweden extend the use of joint assessments to include the Swedish translations of package labelling and leaflets, making it possible to obtain joint comments and simultaneous approval in the national stage of the DCP?

Ideally, the use of Nordic packaging would be routine for all pharmaceutical companies that operate in several Nordic countries. The advantages are undeniable and the processes are already in place. But are the companies’ EU marketing authorisation departments sufficiently aware of this opportunity in every instance? It would be very advantageous to have Nordic regulatory experts involved in the process right from the writing of the EN labelling texts. I believe that the Nordic region is home to the best expertise with regard to writing appropriate labelling texts and avoiding the pitfalls that would prevent the inclusion of multiple languages in packaging.

Cooperation reduces availability problems and promotes the placing on the market of new medicines

Launched in 2017, FINOSE is a significant Nordic project that facilitates cooperation on HTA assessments between the Finnish, Norwegian and Swedish authorities. The project plays a substantial role in the development of HTA processes and sharing the workload between several countries. The aim is to make new and innovative medicines available to patients faster. Based on the experiences gained from the pilot phase, the decision was made to continue the project. This form of cooperation is warranted and may become a permanent operating model.

The Nordic Product Number system has been used for the identification of pharmaceutical packages for several decades. The system is administered via the Vnr online service. It is also possible to use the Vnr service under the one-stop principle to submit notifications concerning the placing of medicines on the market, as well as notifications regarding availability problems. Could these features be expanded to cover the other Nordic countries as well?

The Nordic Pharmaceuticals Forum, which was established at the initiative of the Danish company Amgros, aims to bring together the resources of different countries in the procurement of medicines. It operates on a voluntary basis, and not all of the Nordic countries are actively involved yet. Nevertheless, two rounds of joint hospital medicine procurement between Denmark, Norway and Iceland have already been carried out, for example. The aim of the cooperation is to present the Nordic region as an attractive market to pharmaceutical companies, thereby reducing availability problems and promoting the placing on the market of new medicines.

Joint vaccine production in the Nordic region?

The vision of the Nordic Council is that the Nordic region will become the most sustainable and integrated region in the world in 2030. In 2022, the Nordic Council’s themes in the area of health and social welfare include health preparedness, the security of supply, the use of health data, and children’s medicines.

During its Presidency of the Nordic Council last year, Finland introduced an initiative to develop Nordic cooperation regarding the security of supply, and Finland also supports Sweden’s initiative regarding Nordic vaccine development and production. Indeed, in

November 2021, the Nordic Council made the following recommendations to the governments of the Nordic countries:

• ensure funding for Nordic vaccine research
• launch Nordic cooperation on vaccine production
• actively engage in multilateral cooperation to prevent patent restrictions and deficiencies in technology and the exchange of information from creating obstacles to the quick and cost-effective prevention of the spread of pandemics.

Together with our Nordic colleagues in the pharmaceutical sector, we will keep a close eye on the actions taken in response to the above recommendations.

Writer

Pirkko Talvio, Unit Head (Regulatory Services), DRA Consulting