No 3 - 2017

The Danish state's vaccine production business has now been divested

As per 16 January 2017, Statens Serum Institut (SSI) has completed the carve out of its vaccine production business to AJ Vaccines A/S and divested all its shares to AJ Vaccines Holding ApS. As of now, AJ Vaccines A/S will produce vaccines against, e.g., polio and tuberculosis at the SSI’s premises on Amager, Copenhagen.

AJ Vaccines A/S has taken over the SSI’s vaccine production business, including marketing authorisations, and employees. More than 500 employees at the SSI have thereby changed employer. Statens Serum Institut, under the auspices of the Ministry of Health, remains responsible for ensuring the supply of vaccines to the Danish childhood vaccination programme, preparedness vaccines, and other necessary preparedness products.

The sales agreement was signed in June 2016. Prior to the completion of the sale, a comprehensive carve out and transfer process was needed, and a range of new it systems needed to be established. These tasks have now been completed and the responsibility for the production of a range of vaccines against viral and bacterial diseases has therefore been transferred to the buyer. This includes, among others, vaccines against tuberculosis, polio, diphtheria, tetanus and whooping cough.

To ensure continuity in the childhood vaccination programme, the sale of the SSI’s vaccine production business includes an agreement with the buyer to supply vaccines for the childhood vaccination programme during a 30-month transition period. A public tender to be initiated in the first half of 2017 will determine which company will subsequently supply vaccines for the programme.

New strategy for a more focused SSI

The changes at the SSI have provided an excellent opportunity to prepare a new mission and strategy to both reflect a leaner SSI and ensure that the Institute will remain at the forefront coping with any new disease-related challenges.

”We aim to reinforce health through disease control and research”, is the Institute’s new mission that is strategically focused on three health priority areas:

• Infectious disease preparedness 
• Biobank and biomarkers
• Research

Ensuring a strong national infectious disease preparedness framework

Growing worldwide antibiotic resistance, increased mobility of people, animals and food among countries, and climate changes causing increased incidence of, e.g., malaria and dengue fever. These are only some of the factors that demand a strong programme of infectious disease preparedness to prevent, investigate and curb disease outbreaks. In Denmark, Statens Serum Institut is responsible for infectious disease preparedness.

At the new SSI, infectious disease preparedness brings together laboratory-based and epidemiological expertise, including - among others - monitoring of infectious diseases, special diagnostics, vaccine supply, outbreak preparedness and the Danish preparedness framework against bio-terrorism.

In a world with increasing cross-border mobility of people, food and microorganisms, the expertise and competencies of Statens Serum Institut are more important than ever. Through infectious disease surveillance, special diagnostics and international collaboration, the SSI provides infectious disease preparedness and counselling to Danish healthcare institutions and authorities that are crucial to the health of the Danish population.

Research into new diagnostic methods and treatments

Life expectancy in Denmark is increasing and the prevalence of chronic diseases, lifestyle diseases and cancer is rising. The prevention of infections is important in the treatment of these diseases, as patients’ immune systems are often weakened.

Furthermore, new diagnostic methods and treatments are needed. The development of both is among the most important tasks of the health priority area Biobank & biomarkers.

Research into and verification of new disease markers will help ensure a more targeted treatment of these diseases. This is one of the goals that the SSI strives for – both in the Institute’s own research and in the operation and development of the Danish National Biobank, which is a resource available to all researchers.

Top-level international research

All of SSI’s activities are based on research. The SSI provides research-based counselling. Data and new knowledge are gathered and produced in all priority areas, which are communicated to the outside world by SSI employees and published in scientific journals. Each year, the SSI’s researchers publish approximately 400 scientific articles.

Research therefore constitutes a cornerstone and prerequisite for both the Infectious disease preparedness and the Biobank & biomarkers area. Moreover, the SSI houses two world-class research environments. One is epidemiology research, where scientists investigate, e.g., disease aetiology using the unique Danish health registers and biobanks. The other is vaccine research, where scientists investigate the effects of vaccines and develop new vaccines against, e.g., tuberculosis and chlamydia.

Top-level international research is a requirement for the SSI to contribute to solving the challenges facing Denmark and the international community, now and in the future. Therefore, the SSI must remain one of the country’s largest and most important health science research institutions.

Commentary

Over the past 18 months, the staff at Statens Serum Institut has been reduced from 1,400 to approximately 700. This reduction is due to the divestment of its two production areas, SSI Diagnostica and the SSI's vaccine production, as well as to the restructuring of the Danish Ministry of Health, including the establishment of the Danish Health Data Authority.

The separation of these three areas does not alter SSI’s 100-year-old primary duty, namely to combat infectious, hereditary and autoimmune diseases. Also, the SSI remains responsible for the purchase and supply of vaccines to the Danish national vaccination programmes. But the restructuring provides an excellent opportunity to reform the SSI’s mission and strategy both to reflect a leaner SSI and to ensure that the SSI remains at the forefront of new disease challenges. Read more about the SSI's new strategy here.

(Statens Serum Institut)

Link to previous issues of EPI-NEWS

18 January 2017