A Note from the Executive Director

Information dissemination remained one of the Agency's key tasks. Notably, the Agency's response to misinformation spread by a foreign state leader regarding the use of paracetamol during pregnancy garnered significantly more visits and engagement than usual on both the website and social media. This once again highlights the importance of ensuring that the public has access to impartial and professional information, especially in times of information disorder.

Finance and Administration

The new Minister of Health, Alma D. Möller, paid her first visit to the Icelandic Medicines Agency, which operates under the Ministry, during the first full working week of the year. She was accompanied by the Permanent Secretary, the Ministry's Public Relations Officer, and the Ministry Pharmacist. It was a pleasant visit during which the Agency's management provided an overview of its operations, challenges, and future outlook.

During the year, emphasis was placed on securing the Agency's funding in line with the growth of the revenues collected by the Icelandic Medicines Agency, which are transferred directly to the state treasury. Extensive work was carried out throughout the year to revise the fee schedule and fee items for medicines on the one hand and medical devices on the other. A new fee schedule for medical devices came into effect at the recent turn of the year.

The Agency's Pricing and Reimbursement Team began work in May on a wholesale-level price review, which is conducted every two years. This review is based on price comparisons with reference countries and is carried out in accordance with the provisions of the Medicines Act, regulations, and the Agency's internal procedures. The new prices were implemented in the pharmaceutical price list on 1 January 2026. Recent price reviews have resulted in significant savings for the public sector, with last year's review expected to save approximately half a billion ISK annually. This is therefore a project of significant national economic importance.

The year began slowly in terms of revenue generation, and the operating result for the first quarter showed a deficit of nearly 40 million ISK. This was due to increased salary costs, partly as a result of retroactive collective bargaining agreement increases, as well as lower revenues caused by various changes to the EMA fee schedule that took effect at the beginning of the year. In response, the Agency implemented internal restructuring to enhance efficiency and sharpened its prioritisation of revenue-generating projects. Various workflows were also reviewed and revised, including shortening the opening hours of the reception and service centre and discontinuing the rception of expired controlled substances for disposal. These measures, among others, proved effective, and the Icelandic Medicines Agency achieved a positive financial outcome for 2025, marking the third consecutive year of surplus.

Anniversary

The year was significant and full of celebrations. The European Medicines Agency celebrated its 30th anniversary in January, and the Icelandic Medicines Agency marked its 25th anniversary on 1 November. To commemorate the occasion, we hosted an anniversary symposium on 6 November. The topic of discussion was counterfeit medicines, and it was deemed timely to address the significant challenge that society faces in this regard. The symposium emphasised the importance of authorities working together to respond to the threat that such medicines pose to public health and safety.

I welcomed the guests, and the symposium commenced with an address by Alma D. Möller, Minister of Health. She extended her congratulations on the occasion and expressed her gratitude for the Agency's diligent and important work. Following her address, presentations were delivered from various perspectives, including the Icelandic Medicines Agency's regulatory oversight, the chair of a pan-European working group monitoring threats in the production and distribution of medicines, Customs within the Directorate of Internal Revenue, and the Laboratory of Pharmacology and Toxicology.

Most of the Agency's staff followed the symposium via livestream at Vínlandsleið, and we concluded the day with a celebratory gathering in the afternoon.

Human Resources

The Icelandic Medicines Agency is particularly rich in human resources, with highly qualified individuals in every position. At the beginning of the year, two international experts joined the Agency, bringing extensive experience from European medicines agencies. Now three international experts work remotely for the Agency, all of whom are excellent additions to the strong team based in Iceland.

A new human resources policy was implemented during the year, emphasizing employee dedication, the right people in the right positions, and being an attractive workplace. The policy consists of six main objectives, notably that we build success on people's strengths, foster health and well-being, and work together towards an inspiring culture of achievement.

Efforts to maintain equality and fairness in salary matters continued. Following an equal pay audit in May, the Icelandic Medicines Agency's equal pay certification was renewed. According to the results, the unexplained gender pay gap favoured women by 0.56%, representing an improvement from the previous audit.

The annual survey for the "Institution of the Year" yielded an overall score of 4.18, higher than in previous years, with workplace atmosphere, flexibility, and management receiving the highest ratings. Emphasis was placed on health and well-being throughout the year, with various presentations from Auðnast, where staff received education on topics such as stress management and sleep habits.

In October, a safety committee was established to ensure the safety and health of employees through risk assessments and improvements in the working environment.

Digital Solutions and Artificial Intelligence

The year’s operations were largely characterised by technological innovations and system upgrades. Significant efficiency gains can be achieved by streamlining communication channels and making services and case processing more accessible. During the year, work was carried out to update processing systems and implement a new web service for medicine shortage notifications. Additionally, access to information on medicine shortages was greatly improved by providing data for each medicine in the Icelandic Medicines Register and certain prescription systems used by doctors. Medicine shortages remain an ongoing challenge and simplifying and improving information dissemination is highly beneficial in reducing the burden on the healthcare system and medicine users. To address this, a meeting was held at Vínlandsleið with stakeholders from wholesalers, marketing authorisation holders, Landspítali (National University Hospital of Iceland), Icelandic Health Insurance, the Capital Area Primary Healthcare, and various stakeholder organizations.

The vision for digital solutions has been a central theme everywhere throughout the year, and the Icelandic Medicines Agency was no exception. Artificial intelligence (AI) is a key focus, and it is essential to establish a strategy and engage in this journey from the outset. The Swedish Medical Products Agency shared its AI-based tools with us, and their AI specialist visited the Agency in June to present them. These tools are already in use by 17 European medicines agencies. Around the same time, the Icelandic Medicines Agency introduced its closed AI-powered chatbot, which provides secure and rapid information on medicines and regulations.

The development of new solutions is an ongoing endeavour, and the Icelandic Medicines Agency will continue to play an active role in this work. For instance, the Agency contributed to the development of Icelandic language technology by providing Almannarómur, the Icelandic Centre for Language Technology, with nearly 4,000 text files from the Icelandic Medicines Register. This contribution, which consisted of professionally reviewed texts in specialized Icelandic, was the largest data submission Almannarómur has received and will influence the development of language technology and AI solutions for health sciences.

International Collaboration

The collaboration between medicines agencies within the European Medicines Agency (EMA) network followed the same structure as previous years. Experts from the Icelandic Medicines Agency regularly attended meetings in various committees throughout the year, either abroad or via teleconferencing. Cooperation with our sister agencies in the Nordic countries and within the EEA region was equally important. For example, the joint Nordic pilot project aimed at improving access to essential but rarely used hospital medicines continued throughout the year and has grown and strengthened since its inception. Additionally, a new pan-European portal for clinical trials (CTIS) was introduced, facilitating access for healthcare professionals and the public to information on ongoing trials in Europe. The Icelandic Medicines Agency contributed to its development.

The Icelandic Medicines Agency has achieved outstanding results in regulatory processes and scientific advice, as reflected in its contributions to European projects. This success is built on strong teamwork, expert knowledge, and coordinated project management, representing a particularly gratifying achievement for an agency of our size.

Safety

One of the objectives of the Icelandic Medicines Agency is to increase the availability of medicines on the Icelandic market and reduce the number of exemptions for unlicensed medicines. The aim is to create greater predictability for healthcare professionals and medicine users, thereby reducing uncertainty and enhancing safety. In February, one of the most commonly used unlicensed medicines, progesterone capsules, was marketed, which will significantly reduce exemption requests. In 2025, applications for unlicensed medicines decreased for the second consecutive year, with 2024 being the first year in many years to show this trend.

However, it is not only unlicensed medicines that require monitoring. Counterfeit medicines are a growing global threat, and with improved access to online sales platforms, the need for active surveillance has increased. This was evident in the international Europol operation, Operation SHIELD VI, in which Icelandic Customs participated with the support of the Icelandic Medicines Agency. Domestically, over 5,000 vials of illegal peptides were seized, all of which had been shipped from China via postal or express delivery services. When the operation was publicised, I had recently given an interview to RÚV about illegal peptides and their purchase by young people on social media.

The Agency's tasks cover a wide range of activities to ensure public safety. Adverse reaction reports are continuously monitored and followed up on, the Agency participates in international campaigns on the proper use of medicines, and oversight is maintained over most aspects related to medicines and medical devices. However, not all tasks are predictable. Following a fatal accident, the Icelandic Transport Accident Investigation Board requested that the Icelandic Medicines Agency improve the labelling of medicines that may impair the ability to drive or perform tasks requiring full alertness. The Agency responded immediately by tightening the requirements for labelling medicines with the red warning triangle.

The diverse tasks successfully completed under challenging circumstances this year reflect the significant human resources the Agency possesses. Now, we look ahead and continue our daily work to ensure the safety and well-being of the public. Like other medicines agencies, we always face plenty of challenges. Next on the agenda for all of us is the new European pharmaceutical legislation, which will be implemented in phases from 2026 to 2028.