A Note from the Executive Director
At the beginning of the year, it was clear that another COVID winter had begun, as the Omicron variant of the virus had spread very rapidly in the preceding weeks. Work on issues related to the pandemic continued to a significant extent in 2022, although the workload decreased considerably as the year progressed.
Many other demanding tasks were undertaken, some related to laws and regulations, others related to changes in retail pricing of medicines in pharmacies, new digital systems were implemented, and medicine shortage issues were of great concern. However, what was intricately woven into all the projects of 2022 were the housing matters of the institution, as changes to the housing at Vínlandsleið began in November 2021.
The impact of the pandemic was significant at the beginning of the year, with the rapid spread of the Omicron variant of the Sars-CoV-2 virus in the first months of the year. The staff at the Icelandic Medicines Agency (IMA) was greatly affected, as they had to deal with illnesses and quarantine to a greater extent than before. It was therefore considered necessary to highlight the delays in processing tasks on the website and to emphasize that COVID-related matters were a priority. In the early part of March, the burden of the pandemic on the healthcare system became so great that IMA, in collaboration with primary healthcare in the capital area, implemented a temporary exception allowing the dispensing of Parkódín (containing paracetamol and codeine) without a prescription in pharmacies, with certain conditions. This relieved some of the burden on primary healthcare.
Although all preventive measures were lifted on February 25th, the burden due to the pandemic gradually decreased throughout the year. Adverse event reports significantly decreased compared to the previous year, although a small spike occurred in the fall following booster vaccinations. Nevertheless, work continued on evaluating and approving new vaccines, modifications to existing vaccines, and other COVID medicines throughout the year. The pharmaceutical surveillance team met with Nordic colleagues in the fall, where vaccines and associated adverse effects were a major discussion point, and the team shared lessons learned from mass vaccination at a conference on safe medicines held domestically in the fall. Thus, COVID matters were not behind IMA, rather than the pandemic as a whole.
Urgent actions and quick solutions
Various projects throughout the year called for urgent action and swift solutions. From late summer and onwards until the end of the year, there was a significant and ongoing discussion about medicine shortages, as reports of shortages increased significantly compared to previous years. The situation was deemed serious, and in September, representatives from IMA were requested to attend a meeting with the parliamentary welfare committee to clarify the state of affairs. The medicine shortage was addressed in various ways, such as utilizing a provision in Article 52 of the Medicines Act that allows IMA to authorize pharmacists in pharmacies to modify a physician's prescription into an emergency prescription for a medicine on a named patient basis. Such measures were among the most visible ones, but behind the scenes, the medicine shortage team worked extremely diligently to prevent any supply gaps. E.g. the team managed to avert a severe shortage of an essential medication in late October.
In June, concerns arose about monkeypox spreading to the country, and in late July, the World Health Organization (WHO) declared a global emergency due to the disease. This inevitably led to media inquiries about vaccines, but shortly afterward, it was reported that the European Medicines Agency's expert committee had recommended the use of an old vaccine against smallpox in response to the outbreak of monkeypox.
At the end of July, the decision was made to recall the emergency medication Theralene. The reason for the recall was that dosage recommendations could be misleading given the administration method of the medicine. This had led to overdosing and subsequent toxic effects.
In early August, a cyber attack was launched against the systems of IMA. The attack affected the medicinal product information database, the service systems for My Pages, and the medicine price access system. Traffic to these websites was immediately blocked, and extensive efforts were made to identify the attack, mitigate its effects, and restore the systems'. This was accomplished in an incredibly short time, and likewise, it could be confirmed that no personally identifiable data had been stored in the mentioned areas.
Furthermore, in the middle of summer, an international operation took place under the auspices of Interpol, Pangea XV. A significant number of illegal drugs and medical devices were seized. IMA participated in the operation in collaboration with customs officials from the Icelandic Revenue and Customs Authority. The emphases of IMA and the Revenue and Customs Authority in the Pangea XV operation was on counterfeit medicines in postal shipments.
Work related to various laws and regulations was done throughout the year. In late January, a new veterinary medicinal products legislation came into effect in the EEA area, and simultaneously, a large database was opened by the EMA, containing information on all veterinary medicinal products that have marketing authorizations in the area, in the language of each country as applicable. A proposal regarding nicotine pouches emerged in the spring, with significant involvement from IMA in its development since there had been considerable discussion about whether to define the pouches as medicines. However, according to the proposal that became law in the summer the puches are not defined as such. Representatives of IMA and the Medicine Committee of the National University Hospital of Iceland presented joint suggestions to the authorities on amendments to regulations regarding the licensing obligation of medicines. IMA was requested to provide an opinion on a proposal that allows increased access to over-the-counter medicines, and a new regulation on pharmaceutical licenses and pharmacies came into effect on January 1, 2023, e.g. allowing pharmacies that operate exclusively as online drugstores. A new regulation on in vitro diagnostic medical devices came into effect in May, and significant work was also undertaken in the implementation of a provision stating that all clinical drug trials must go through the European gateway from January 31, 2023. A preparatory presentation meeting on the latter took place on January 11 in the new year.
During the first part of the year, diagnostic work was introduced in the ministry regarding the revision of the retail pricing of prescription medicines in pharmacies. Numerous meetings were held with representatives of retail pharmacies, followed by another meeting with the ministry in May, and on May 20th, a decision was announced. The first amendment was scheduled to take effect on July 1, 2022, while the subsequent ones in the first part of the year 2023, including the new provision that pharmacies would receive a service fee from the beginning of the year for dispensing the lowest-priced medicines in reference price categories. Alongside the decision, IMA proposed to the Minister of Health that measures should be taken to provide support for maintaining the operations of rural pharmacies, as well as to provide separate compensation to pharmacies for defined aspects of pharmaceutical services that pharmacists can provide. A working group under the auspice of the ministry with participants from IMA then commenced work in the fourth quarter of the year. The group was tasked with assessing the status of pharmaceutical services and making recommendations for improvements.
Pharmacy staffing was also discussed during the year. A survey on pharmacy services conducted by Gallup on behalf of IMA at the beginning of the year showed that access to pharmacies was very good, but two out of every three customers did not receive counselling when purchasing medication. In May, the Ministry of Health ruled on the cases of two pharmacies that had appealed the decision of IMA regarding an exemption from the staffing regulation of the Pharmacy Act. The outcome was that the decision of IMA should stand.
As has been custom spring meetings were held with stakeholders. They took place from May 9th to May 24th, and according to the survey conducted afterwards, there was generally high satisfaction with the outcomes.
IMA's premises renovated
Work on renovations on the second floor of the housing on Vínlandsleið began in November 2021. Prior to that, the team of employees had been divided into two groups, alternating between being present on the third floor for one week and working remotely the next. There was also an option to book a seat for in-person presence during the remote work week if there were any available. This required excellent planning and management, and the whole process went smoothly, more or less, and actually better than could be expected. The same arrangement was maintained while the third floor was renovated. Shortly before Christmas, everyone could come together at Vínlandsleið, and it was definitely easier to set aside the remote meeting systems and have face-to-face conversations.
Administration, strategy and organization
The foundation for the new strategy of IMA for 2022-2025 was laid at the end of 2021 when all staff members came together for a strategy meeting and presented ideas for defined projects, such as future vision and roles. Managers then worked on these ideas together with a consulting firm, and the strategy was ready early in 2022.
The development of implementing and updating various digital systems continued throughout the year. Calls were transferred from Skype to Teams, and customers were offered service through online chat. The service hours were also changed, offering continuous support through phone, online chat, and reception from 9 am to 3 pm.
Power BI was implemented for reports and analysis findings of various kinds after a detailed comparison of different systems. Various dashboards were utilized to provide an overview, and work was done on a new database for notifications of adverse events. At the end of the year, it was confirmed that digital data transfers from the case and contract system had been approved by the National Archives. The English version of the website was aligned with the main site, a fresh and innovative version of the latter was associated with the 20th anniversary of IMA in November 2020. The most significant improvements in the digital field were in the new and enhanced medicinal product information database. Work on it had been ongoing for months in collaboration with Hugsmiðjan, focusing on both visual and user-friendly enhancements and various innovations, such as displaying information about medication shortages when a specific unavailable medicine is searched. The new medicinal product information database was launched in early December with a presentation for employees.
Changes were made to the organization of IMA in August. It was clear that the institution had faced unexpected and complex circumstances from various angles in the preceding months. Among other things, there was an increased role on the international stage, as well as domestically following new pharmaceutical laws that came into effect at the beginning of 2021. The main organizational change was that the office of the director became a separate department with a new department head, Guðrún Helga Hamar. Þórhallur Hákonarson took over as the deputy director in place of Sindri Kristjánsson, who resigned to pursue other opportunities.
Pay equality has been at the forefront of IMA in recent years. The process formally began in 2020 when the equal pay management system was certified, and the unexplained gender pay gap has continuously decreased. Then, in the beginning of the summer, the joyful results from the annual salary survey were revealed, showing that there was no unexplained gender pay gap within the organization.
In the autumn days of 2021, a government report was published on increased cooperation between Iceland and the Faroe Islands, including pharmaceutical matters and potential areas of collaboration in that field. Among the recommendations was the establishment of a specific agreement between IMA and the Pharmacy Authority in the Faroe Islands, Apoteksverket, which became a reality in March 2022. The director and Hjalti Gunnarstein, the national pharmacist in the Faroe Islands, signed a declaration of intent regarding cooperation between the nations in the field of pharmaceutical affairs. In August, representatives from the regulatory surveillance division og IMA visited the Faroe Islands, where they gained insight into the daily operations of the national pharmacy.
Meetings of the directors of the Nordic pharmaceutical agencies had been conducted remotely during COVID, but in September, the group finally met in person in Helsinki, having not seen each other in person since January 2020. Additionally, the European directors met in person for the first time in nearly two years in March. It was also their first meeting in the new building of the European Medicines Agency (EMA) in Amsterdam.
As before many projects related to the EMA were on the agenda. In addition to the regular work in various committees, two of our inspectors went on a site inspection to a manufacturing site in Indonesia, and the pharmacovigilance team received additional projects from the EMA, which could be seen as a sign that our reputation in the field was strengthening. Furthermore, many employees of IMA participated in various Nordic collaborations as usual. E.g. a working group project that focuses on cooperation among the Nordic countries regarding access to medicines for children was carried out.
An educational trip of IMA staff to Amsterdam in September strengthened the foundations of international collaboration in various ways. We visited the headquarters of the EMA, the Ministry of Health, and the Dutch Medicines Agency. Furthermore, we took the opportunity to have the annual celebration of IMA in Amsterdam. It was a rewarding and enjoyable trip in every respect.
Looking back on the year as a whole, we can be pleased with the accomplishments. Many significant milestones were celebrated, and substantial projects were progressing well. Moreover, there were even indications that the pandemic would no longer IMA‘s agenda as it had for a long time. Therefore, we could look forward to the new year with optimism.