A Note from the Executive Director

The pandemic was officially declared over in May, but registration processes for the vaccines remain active, and vaccinations will continue in specific groups. Nevertheless, 2023 was not without major challenges. Key issues were finances and a persistent medicine shortage that needed to be addressed.

Finances

The agency's finances were a predominant and heavy concern throughout the year 2023, with ongoing worries. Most of our meetings with ministry officials were dominated by discussions on funding for the following year and how to address the situation that became increasingly clear as the year progressed. Efforts were made, in cooperation with the Ministry of Health, to secure additional funding for operations, but this was only partially successful. The outcome was that the IMA anticipated having to reduce operations for the second consecutive year, by approximately 50 million ISK in 2024. Consequently, it appeared that the agency would generate higher revenue for the state treasury than it would receive from it, amounting to about 100 million ISK. It was clear that the upcoming year would commence with significant austerity measures. Interwoven with this were concerns about the anticipated new fee schedule of the European Medicines Agency (EMA), and its impact on the IMA's revenue. The new fee schedule was set to come into effect in 2024, and a forecasted reduction in fees for scientific advice would have adversely affected the IMA. However, the implementation was postponed to 2025, and the planned reduction in those fees would be smaller than initially anticipated.

Persistent Medicine Shortage a Global Concern

The issue of medicine shortages dominated discussions more than usual this year. At the beginning of the year, a special meeting was held in the EMA's Steering Group on Drug Shortages (MSSG), a group tasked with handling emergencies, severe events that could cause medicines shortages, and threaten public health. The main concern in the European market was antibiotics. There were discussions about whether to declare a state of emergency in Europe due to this, which was done in several countries. The EMA issued a special statement to explain how these challenges were being addressed. Domestically, the Minister of Health requested weekly updates from us on the situation to maintain an overview; the IMA's drug shortage team has diligently provided this summary since. In March, the situation prompted the IMA to call on marketing authorisation holders to increase the availability of antibiotics in the Icelandic market. In August, the European Commission, Heads of Medicines Agencies (HMA), and the EMA issued recommendations to mitigate shortages of essential antibiotics for the winter.

However, there were shortages of more than just antibiotics. The demand for weight management and diabetes medications increased significantly due to media and public discussion both domestically and internationally. This was not limited to Iceland and other European countries but was a global phenomenon. This led the IMA to issue a mid-summer warning that a shortage of the medication was imminent and could persist until the end of the year. This shortage is still partially ongoing, but the manufacturer distributes the available supplies among countries based on production capacity. It was therefore not surprising that deceitful individuals tried to exploit this situation; in October 2023, the EMA warned about counterfeit Ozempic pens found in Austria, Germany, and the UK. No such incidents were found here upon investigation. Similarly, the use of the ADHD medication Elvanse Adult had increased, and shortages became apparent in the autumn. Due to numerous inquiries from both the media and the public, the IMA deemed it necessary to issue a special announcement to guide users of Elvanse Adult. Likewise, general news updates were provided to explain efforts to mitigate the drug shortage issue and the IMA's collaboration with market stakeholders to address the problem.

Pricing and Reimbursement

Medicine pricing issues were very much in the spotlight this year. With the new medicine legislation that came into effect at the beginning of 2021, the IMA was tasked with deciding on the pricing and reimbursement of medicines in the country, including setting maximum retail prices for prescription products. The first decision in this regard was made in May 2022, with changes implemented in three phases. By the time the final phase was reached in March 2023, it had been decided to split the increase in retail margins due to unusually high and growing inflation. Furthermore, the IMA established specific procedures for setting the maximum wholesale price for prescription medicines. The main objective was to ensure that inexpensive medicines, which do not generate significant financial turnover but are essential to prevent shortages, remain on the market.

Decisions on the reimbursement of certain medicines that had long been debated attracted more general attention. One such decision involved the reimbursement of Spinraza for those aged 18 and older, previously limited to those under 18, a medicine used to treat spinal muscular atrophy (SMA). Another involved changes in the reimbursement arrangement for diabetes and weight management medicines Saxenda and Wegovy, in collaboration with the Health Insurance Administration. New information from the Nordic countries, as required, was the basis for this, though it caused some discontent. Earlier in the year, an exemption had been granted for the use of Tofersen to treat amyotrophic lateral sclerosis (ALS).

Information Dissemination - Media and More

Various aspects of the IMA's activities attracted media attention during the year. However, not to the same extent as during the COVID-19 years, when media inquiries had to be addressed almost daily, sometimes multiple times a day. Media attention understandably focused on the suspicion in April of dubious lookups in the prescription database, where prescriptions of well-known individuals were accessed without justification. This matter pertained to the IMA as a supervisory body, but more so to the Directorate of Health, which manages the prescription database.

The discussion about making naloxone available over the counter emerged in April after the U.S. Food and Drug Administration approved its sale in this manner. Icelandic authorities were urged to do the same. As usual, our approach was to align with our European colleagues, and when the Swedish Medicines Agency announced in early 2024 that the nasal spray had been approved for over-the-counter sales, we began exploring the possibilities of this in our country. The treatment of non-professionals with fillers was a topic of considerable discussion in the autumn. This touched on an area where the boundaries between institutions and agencies are not entirely clear, requiring substantial deliberation before issuing our statements on the TV news channel Stöð 2, which primarily encouraged reporting incidents to the IMA.

In general, regarding media and IMA activities, it can be said that the interest in such matters seemed to have increased due to COVID-19. It was clear that the media closely monitored what we communicated and wanted to highlight it themselves. This also applied to medicines-related issues in a broader context, even if they did not directly affect Iceland.

Long-term media attention seemed to have paid off, as a survey on public knowledge and trust in the IMA early in 2023 revealed that 59% of respondents had a high level of trust in the IMA, and 35% felt well-informed about its activities. Knowledge had increased by 5% year-over-year and had been steadily rising since measurements began.

Information was also disseminated through other means than the website or media. For instance, an information meeting on the upcoming changes to the clinical trials application process was held in January, as part of an adaptation process to the European application and processing portal, CTIS. The meeting was conducted via the Teams communication platform. Our staff, along with a representative from the National Bioethics Committee, presented the forthcoming changes, and participants, primarily from the scientific and medical community, had the opportunity to ask the experts. A new website containing information about marketed medicines in Iceland, introduced in December of the previous year, was showcased at the an Expo for Physicians in January. Staff presented the new features of the register to doctors and offered an entertaining three-part challenge involving finding specific information on the website in three different ways, which was well received.

International Collaboration

At the beginning of the year, significant effort was put into preparing for the BEMA evaluation, which took place in mid-May. BEMA stands for Benchmarking of European Medicines Agencies, a benchmarking system established by the heads of European medicines agencies in 2004. Its goal is to harmonise standards and professional requirements that the agencies operate under, with evaluations conducted every four to five years at each site. The work involves both self-assessment by each agency and peer assessment where experts from other agencies review processes and standards.

There were other pleasing aspects of international cooperation. Twice, two members of the IMA staff were appointed to EMA committees, which is unusual since usually only one representative from each EMA member agency is on the committees. This was simply due to the outstanding competence of our specialists. Additionally, various other experts were called upon for advice both domestically and internationally, by institutions, committees, and companies. Routine meetings with the directors of the Nordic and European medicines agencies often focused on European pharma legislation and changes to the EMA fee schedule.

Organisation and internal Operations

Organisational changes that took effect at the beginning of the year involved transfers between units, a necessity for an organisation attempting to adapt to societal changes and needs. There was considerable movement among staff during the year. Efforts were made to strengthen certain aspects of operations and enhance efficiency, but when the requirement for rationalisation emerged mid-year, it was not even possible to fill the vacancies left by those who moved on to other areas, for studies or work. The demand for rationalisation became increasingly pronounced as the year progressed.

The digital transformation of the organisation had been underway for several years. Despite the COVID-19 period, we managed to launch a new website around the time of the 20th anniversary of the Medicines Agency, as well as a new website for the medicinal product register and an English version of the main website in December 2022. A special annual report website was added in 2023, and the simpler domain lyf.is was added to the older medicinal product register site for user convenience. All of this was exemplary, and it was gratifying when the agency was nominated for the Icelandic Web Awards in March, even though it did not result in an award.

The implementation of the new WorkPoint case management system continued, and the communication portal "Hafa samband" was opened, making it especially easier for individuals to communicate with the agency. Additionally, the portal allows cases to be automatically assigned to specific departments or divisions according to the subject matter selected by the user. Both of these measures are aimed at increasing efficiency.

During the year, the renovation of the premises in Reykjavík was completed, providing a real reason to celebrate with good guests. We hosted two large gatherings in August. On the one hand, we welcomed the Minister of Health, ministry staff, representatives of partner organisations, and trade unions. On the other hand, we reunited with former colleagues, which led to joyful reunions. It was a pleasure.