Is Sweden prepared for an outbreak of ebola?

The current outbreak of the Ebola virus has appeared to be getting more severe by the day, but we may be entering another phase now when the overall number of new cases is levelling off. However, it is the largest and most complex outbreak to date, with over 14,000 cases reported and more than 5,200 deaths. According to other sources 12,000 deaths would be a better estimate. The current outbreak represents the widest geographical spread of the disease ever reported and headlines about new outbreaks are yet to come. There is still no marketapproved drug for treating Ebola and no vaccine to prevent it. As of last month, Ebola was reported in Scandinavia, raising questions about how well prepared Sweden is and; most of all whether current legislation is flexible and secure enough to combat this type of threat. 

It takes on average more than 12 years to develop a new medicinal product. Once clinical trials have been completed, a pharmaceutical company may apply for marketing authorisation. Approval is granted after extensive scientific evaluation of how the new medicine works, its potential side-effects and manufacturing requirements. The quality, efficacy and safety requirements for a medicine are very high.

There is no doubt that when diseases like Ebola strike our society, and time is short, a fast track approval is required alongside the standard authorisation procedure. In Sweden, the standard authorisation procedure for medicines that have been tested on humans usually takes around 210 days, but there is a possibility of releasing untested medicines on the market even if they have not been evaluated for safety and efficacy in humans. In fact, the Swedish Medical Product Agency (MPA) may allow the prescription of a medicine to specific individuals by issuing a special license in less than seven days. Similarly, the US Food and Drug Administration has allowed the use of untested medicines to fight the deadly Ebola virus in humans. The decision was based on humanitarian reasons.

In both the US and Sweden, fast-track approval raises a lot of questions. Not only in terms of the very short timeframe within which the authority has to gather information on the medicine and review it, but also, in terms of how such information is gathered. Furthermore, there are no provisions or guidelines regulating what ethical points to consider in making such a decision. An even greater factor is, of course, the uncertainty over whether improvements in patients’ conditions are actually due to the treatment and what side-effects may transpire in future. One should not forget that the fast track is used for medicines which are still at an early stage of development and only some of these medicines have shown encouraging results in the laboratory or in animals, but they have not yet been fully studied on humans.

Health authorities around the world have struggled with the ethical issue mentioned above, which was the subject of a recent report by the World Health Organisation (WHO). The WHO concludes that it is ethical to offer untrialled medicines with unknown effects and side-effects in the fight against Ebola. However, the following ethical criteria should be fulfilled: (i) transparency concerning all aspects within the health care system; (ii) the patient must be informed and have given consent; (iii) the patient should have a freedom of choice; (iv) the treatment is confidential; (v) the individual is respected; and (vi) preservation of dignity and participation in society. WHO is also of the view that a treatment includes a moral obligation to evaluate efforts in order to definitively demonstrate safety and efficacy or possibly to stop the use of the treatment. Moreover, and in order to provide information about the available experimental medicines, the European Medicines Agency (EMA) has started reviewing available information on Ebola treatments currently under development. The goal is to provide an overview of the current state of knowledge about these medicines to support health authorities in their decisions. Furthermore, the EMA Committee for Medicinal Products for Human Use will perform a formal review of the available scientific information on quality, preclinical and clinical data about various treatments under development.

The Swedish MPA has declared that Sweden is prepared for an Ebola-outbreak. But the facts remains that there are still no approved medicine either to prevent or to treat Ebola and an outbreak in Sweden would put great pressure on hospitals and other health care institutions to be prepared and to act in such a crisis.