This column has so far commented three times on the issue of Sopharma, a pharmaceutical company in Bulgaria that was previously owned by the Municipality of Sofia, which was privatised in September 2000 under rather colonial terms.
Traps and pitfalls for Borisov (New Europe, 30 October 2011), Conflict of interest: Bulgaria sets new record (13 November 2011), Petty interests downgrade image of Bulgaria and Borisov (9 December 2011).
Sopharma, controlled by Ognyan Donev, who until a year ago was a member of the supervisory board of the State Authority National Health Insurance Fund, has managed to supply more than 70% of the medicines required by (state) hospitals and more than 50% of prescribed medicines – an extremely profitable business, for which Donev deserves congratulations, but since Bulgaria is not a member of the AU (African Union) but of the EU, this situation must stop, as it is in flagrant violation of EU law.
We have learned that the European Commission is already in Bulgaria, investigating the case 'sur place' and we are confident that it will restore the functions of the free market in that country. We are often critical of Commission services for various reasons, often correctly, sometimes wrongly, but we have to admit that EU fonctionaires are stubborn enough not to give in to political pressure from member states or cabinets.
Key to the Sopharma case are two Bulgarian personalities. First, the owner, Ognyan Donev who set things up in such a way as to monopolise the Bulgarian pharmaceutical market with his company while he was a member of the supervising medicines authority, the National Health Insurance Fund, which is unethical (and illegal) even in AU (African Union) member states.
Second, the current deputy health minister of Bulgaria, Gergana Pavlova, a former high-ranking employee of SOPHARMA, is now the political supervisor in the Boyko Borisov cabinet in charge of medicines and hospital supplies.
Indeed Pavlova managed to pass a law which, by pure coincidence, provides great benefit to the company for which she was previously working. Among others, the new Pavlova law provides for the direct purchases of medicines by hospitals, with the result that in 80% of cases, prices paid to Sopharma are now higher.
Those interested to learn what additional cost this implies for the Bulgarian state budget during a recession can choose a small number of hospital directors at random, speak to them and then extrapolate the number for the total number of hospitals affected by such a provision.
Another aspect of the Pavlova law is the authority granted to medical centres to conduct clinical trials of medicines. Such powers, so far, were limited to state hospitals, but Sopharma is already conducting a number of clinical tests with medical centres.
Furthermore, and this is very important, the new Pavlova law has deprived the Supreme Council of Drugs of the authority to issue drug licences, and has passed such authority to one person, the director of the Bulgarian Drug Agency, Alex Yankov.
There are many other aspects of the Bulgarian pharmaceuticals mega-scandal involving specifications of equipment purchased by the health ministry and a particular supplier as well as the destruction (but not because they have passed their sell-by date) of €1 million worth of vaccines that are much needed by the children.
These are issues that will be analysed in our coming issues as they not only violate community law but also affect public health in an EU full member state.