Read report: Improving availability of needed medicinal products with low sales volumes and low profitability in Norway: Survey of pharmaceutical industry
The companies’ responses show the importance of the pharmaceutical authorities in Europe offering incentives. The main aim of the survey was to obtain a better overview of the incentives that are most relevant and attractive to pharmaceutical companies.
“Not surprisingly, predictability with regard to revenues is the most important factor when companies make marketing decisions. Low prices and low sales volumes topped the list of reasons why medicines are withdrawn from or not marketed in Norway,” says Senior Adviser Andreas Sundgren, who was responsible for the survey.
Medicines for children and antibiotics
Small markets with few patients are not very attractive to pharmaceutical companies. The result is poor availability of particularly old, but good medicines which are still in demand. This situation is not unique to Norway, as it is a challenge that we share with other countries with small patient groups. For example, many EU-approved medicines with suitable paediatric formulations are not readily available for children in the Nordic countries either because they are not marketed here or because they are withdrawn from the market. A project funded by the Nordic Council of Ministers has looked at the possibilities that exist for closer Nordic co-operation aimed at increasing the number of approved paediatric medicines available in the Nordic region.
Older antibiotics are another example of medicines which, due to their low price and sales volumes, are disappearing from the market. In this regard, Norway and other Nordic countries are in a unique position, as we still use the narrow spectrum antibiotics as our first choice treatment. The Norwegian Medicines Agency has taken the initiative to carry out a project where we mapped the instruments that we have at our disposal to improve the security of supply of vulnerable antibiotics. As part of this work, we are assessing whether there are any measures that we can implement. In the short term, this could for example be increasing the price of vulnerable antibiotics. In the longer term, it could be measures that require budgets and regulatory changes.
Incentives being offered
The Norwegian Medicines Agency has drawn up a list of medicines that we want to see available on the Norwegian market. We are currently actively offering a raft of incentives to retain or have medicines marketed in Norway, including fast-track national procedures and regulatory easing, such as the waiving of registration fees.
“We are doing our best with the tools that we have at our disposal. We could consider a higher maximum price for single packs, but companies appear to be more interested in price guarantees and financing models that can compensate for low sales volumes. Responses to the survey also confirmed our impression that decisions are made at the international level. Once a decision has been made to withdraw a medicine, it is usually too late to offer incentives,” says Sundgren.
“We have had a very productive collaboration with both The Association of the Pharmaceutical Industry in Norway (LMI) and Farma Norge, who provided excellent input in connection with both the preparation and implementation of the questionnaire. The responses from the companies will be useful in our further work and are also being presented to our European colleagues,” says Sundgren.
Incentives that were of most interest to the respondents:
- Simplified application procedures
- Reduced documentation requirements
- Exemption from requirements for Norwegian packaging
- Determination of maximum price in advance
- Waived fees
About the questionnaire:
The questionnaire was distributed to all companies with marketing authorisations in Norway. The results are based on responses from 71 pharmaceutical companies, with 75% of the respondents being represented in a Nordic country.
The survey was prepared in partnership with the Association of the Pharmaceutical Industry in Norway (LMI) and Farma Norge, which represents manufacturers of generic medicines. Responses were collected during the summer of 2022.
The survey is divided into three parts and includes questions about: Why do companies not apply for marketing authorisation, why are approved medicines not marketed, and why are medicines withdrawn from the market?
The survey was conducted as part of a Nordic project funded by the Nordic Council of Ministers. The Norwegian Medicines Agency was tasked with leading the project group that was to look at possible ways of ensuring that more approved paediatric medicines are marketed in the Nordic countries. The companies were therefore also asked whether they held marketing authorisations for paediatric medicines in the EU. 62% of the respondents had at least one paediatric medicinal product registered in the EU.