A Note from the Executive Director

In previous years, discussions about COVID-19 and vaccines had occupied a significant part of the agency’s activities, but there was little of that in the past year. As in previous years, medicine shortages were a notable issue, and preparations began for a new EMA system to screen for and monitor shortages in the EEA during the year. The new system was officially launched by EMA at the beginning of 2025.

Finances

The government's efficiency requirement had already been introduced by mid-2023. In the 2024 budget, the allocation to IMA was subsequently reduced by ISK 63 million, making it significantly lower than the fees collected by the agency according to law, which go into the state treasury. However, the largest part of the agency’s income, 75%, comes from fees charged for services provided. It was clear that the austerity measures that had been in place throughout 2023 would continue, and therefore efficiency measures were implemented in the form of structural changes and streamlining.

Extensive Structural Changes

An assessment was made of work, processes, and staffing throughout the organisation, examining where services could be reduced and where tasks could be transferred between units to achieve greater efficiency. One of the most significant structural changes in the agency’s history was undertaken, with a substantial reorganisation of the workplace. Two core divisions were created instead of the previous four, while the support divisions remained two, and the number of managers was reduced accordingly. These changes took effect on February 1st. Every effort was made to avoid staff layoffs, which was successful. These extensive austerity measures indeed yielded results, and the year ended with a profit of ISK 40 million.

Service

In addition to frontline phone and chat services, there were behind-the-scenes conversations with various stakeholder groups that rely on the Icelandic Medicines Agency's services and advice. Firstly, the meetings with representatives of pharmaceutical companies, which have been a regular feature for the Agency's management for several years, should be mentioned. There were ten such meetings in 2024 with an equal number of companies. These meetings are intended for mutual information exchange and discussion and have been exceptionally beneficial. It is crucial for the Agency to hear the main concerns of key stakeholders and follow up as needed.

In the spring, I, along with experts, spoke with people interested in psychedelics who wanted to understand what is permitted and what is not, as this issue was prominent in discussions last year and remains so.

It is also worth mentioning that in a survey conducted by the Federation of Icelandic Industries in December 2023, the Icelandic Medicines Agency performed excellently. The survey asked industrial company managers to evaluate the performance of regulatory agencies. Compared to thirteen other agencies, the Icelandic Medicines Agency ranked first, with 50% of respondents rating the Agency's regulatory work as "good."

Domestic Collaboration

The staff of the Icelandic Medicines Agency participated in various domestic collaborative projects as always. Notable examples include work on the Ministry of Health's white paper on pharmaceutical services in pharmacies, a follow-up project to the "Medicines Without Harm" symposium from the previous year, which aims to reduce the use of sleeping pills among the elderly. Additionally, there was collaboration with Iceland Revenue and Customs in the Operation SHIELD IV project, an international Europol operation targeting the trade and import of illegal drugs. Furthermore, a specialist from the Icelandic Medicines Agency participated in the Ministry of Health's harm reduction working group, whose role is to draft the government's policy in this area and propose an action plan. The report was submitted at the end of November. I was part of the Minister of Infrastructure's task force on remote work, and the minister approved the task force's proposal for a ISK 150 million allocation from the regional development plan. The Icelandic Medicines Agency also participated in the government cooperation committee overseeing market surveillance in Iceland. The committee launched the website "Vöruvaktin," where notifications about recalls, defective products, and educational materials useful to consumers are published. Additionally, the Icelandic Medicines Agency has a representative in the steering group on digital development in the healthcare sector, which works on policy and actions in this area under the leadership of the relevant ministry.

Medicine Shortages

Shortages of medicines are a persistent challenge in the work of the Icelandic Medicines Agency. The team responsible for this area monitors the situation continuously and is in constant contact with importers, among other things, to temporarily supply medicines without marketing authorisation when there is a shortage of marketed medicines.

The shortage that was particularly prominent in 2024 was related to diabetes and weight management medicines. The shortage had been ongoing since the previous year, as such medicines had been promoted on social media as a quick solution for overweight, especially the diabetes medicine Ozempic. The Medicines Shortages Steering Group (MSSG) of the European Medicines Agency issued recommendations to address the shortage. These recommendations included finding ways to collaborate with marketing authorisation holders to manage available stock as fairly as possible and prioritise those with the greatest need. Furthermore, the steering group held a workshop in mid-summer to follow up on the recommendations.

At a meeting between the Icelandic Medicines Agency's management and representatives of the Ministry of Health in the autumn, shortages were discussed, and emphasis was placed on setting legal requirements for suppliers to maintain a defined safety stock in the country.

At the European Medicines Agency, work was systematically carried out during the year to establish a system to screen for and monitor drug shortages in the EEA region, a system that enables an overview of the supply, demand, and availability of essential medicines. The system was launched at the beginning of 2025 after a few weeks of adaptation.

Improving Accessibility

Various measures were taken to improve access to medicines, but the small size of the Icelandic market limits supply in many ways, especially for medicines for rare diseases. In October, broader authorisations were granted to exempt packaging labels. These primarily concerned medicines that are only used in healthcare institutions and are not dispensed to patients. The condition is that the labels are in English or one of the Scandinavian languages and do not contain information that is deemed necessary to be in Icelandic.

Similarly, the work of the Nordic Medicines Agencies on a pilot project with leaflets and packaging for hospital medicines aimed at improving access to essential medicines for hospital use. Leaflets and packaging will be shared with English-speaking countries, simplifying production and distribution. The project began in early 2025 and will last for five years.

In March, news came that the Swedish Medicines Agency had authorised the sale of naloxone over the counter. The Icelandic Medicines Agency was interested in following the same path, as opioid addiction is a growing problem in Iceland as elsewhere. Naloxone is an antidote to opioid overdoses. In mid-year, it became clear that the biggest obstacle to making the drug accessible in Iceland is the contractual obligations of the marketing authorisation holder in Norway with third parties. In December, Medicines Agency experts met with the marketing authorisation holder of Ventizolve, naloxone nasal spray, to further explore the possibility of marketing the nasal spray as an over-the-counter medicine in Iceland, and hopes were somewhat raised that a solution would be found.

Equal Pay System and Environmental Issues

In early November, the annual salary analysis was conducted at the Icelandic Medicines Agency in connection with the audit and maintenance of the organisation's equal pay certification. The results revealed that the gender pay gap is within the benchmarks of the equality plan and much better than the previous year; the pay gap was 0.7%, in favour of women. No discrepancies were found in the audit, and it was confirmed that the organisation's equal pay system is designed to achieve its goals and policies in equal pay matters. We are proud of this.

The "Green Steps" project is set up for government agencies that want to reduce the negative environmental impact of their operations and enhance employees' environmental awareness. The Icelandic Medicines Agency has been rapidly advancing in the project in recent months, and in April 2024, the fourth and penultimate green step was completed, a gratifying milestone.

International Collaboration

Collaboration among pharmaceutical agencies under the umbrella of the European Medicines Agency was largely routine. Experts from the Icelandic Medicines Agency regularly attended meetings where, among other things, applications for marketing authorisations and medicine safety were discussed, communication and quality managers attended meetings with European colleagues, and agency managers discussed shortages, EMA software systems, antibiotic stocks, and more. In October, we strengthened ties with the Dutch Medicines Evaluation Board (MEB) when the executive board of the Icelandic Medicines Agency travelled to discuss shortages, registration issues, etc., and also visited EMA offices. This European collaboration is highly valuable, as it is good to compare notes with what others are dealing with, and in some cases, influence the outcome of matters. Equally important is the Nordic collaboration, and early in the autumn, our experts in matters related to addictive and narcotic drugs met with experts from the other Nordic agencies to discuss commonalities in their work.

Technology, Artificial Intelligence and the future

One of the meetings organised by the Nordic countries and Estonia focused on a phenomenon that increasingly came up as the year progressed. Department heads in information technology discussed the topic early in the autumn, artificial intelligence. By then, artificial intelligence had coloured various discussion forums more or less throughout the year - meetings at EMA, meetings of the European pharmaceutical agency directors, communication manager meetings, meetings with ministries, and it even featured in human resources matters when attending a lecture on the future of work in the age of artificial intelligence. However, the technology brings threats that are becoming increasingly concerning. Modern security measures largely involve ensuring cybersecurity, and the Icelandic Medicines Agency's management is very aware that these matters need to be handled diligently. Cyberattacks on Icelandic companies and institutions have increased, and the methods are becoming more diverse.

Security also needs to be considered when it comes to artificial intelligence, ensuring it is not allowed into every nook and cranny. However, artificial intelligence is rapidly entering our reality and has already begun assisting Icelandic Medicines Agency employees with certain tasks. Therefore, when planning for the upcoming major anniversary year of the Icelandic Medicines Agency in autumn 2024, it was decided that it would be the year of artificial intelligence. How significant a role artificial intelligence will play in the operations by the 25th anniversary on November 1, 2025, is impossible to predict, as the development in this area is incredibly fast. But the anniversary will be celebrated appropriately.