An open letter to the Minister of Social Affairs and Health Paula Risikko
Press Release 4.9.2012
The monitoring system for the pharmaceutical industry must be changed and tightened. The present system provides the pharmaceutical industry with the opportunity to cover up medicine-related crimes.
In connection with the background work for our film Sinivalkoinen valhe (When Heroes Lie) we came across cooperation between Orion and the Finnish Ski Association and through this defects in the monitoring and investigation system were revealed. Because the body responsible for monitoring the pharmaceutical industry, the Finnish Medical Agency (FIMEA), bases its investigations on interviews with suspected offenders and does not necessarily carry out further investigations, a situation arises in which possibilities for the pharmaceutical industry to cover up and distort the truth are great. A weak monitory system also protects the pharmaceutical industry from facing a police investigation, that is to say often protecting professions from a more bonafide and broader investigation. There is a great risk that medicine-related crimes and possibly other crimes are not pursued because of failings in the system.
The cooperation between Orion and the Finnish Ski Association meet the criteria of a crime and is a good example of failures in the monitoring of medicines. In May 2001 the National Agency for Medicine (now FIMEA) received a tip that Orion had developed 10% liquefaction agent of Ringsteril specifically for the use of the Ski Association and had delivered it to the Ski Association. The National Agency for Medicine made a request to Orion for an explanation. The request contained three questions:
- Has 10% Ringersteril been made and to which purpose the alleged product had been put?
- If the pharmaceutical product had been made, for whom, and who had the product been sold to or otherwise supplied to?
- How had the product been delivered?
In its reply Orion admitted that 10% Ringersteril had been produced to order in 1996 and had been delivered to the Ski Association. Orion also admitted that it had neglected its own internal procedures. Following this, the National Agency for Medicine submitted further questions regarding the amount and date of the delivery of Ringersteril to the Ski Association. Orion provided the required information and stated that deliveries had taken place from 1996-1998.
No further questions were asked. In its decision the National Agency for Medicine stated that the delivery of medicine to the Ski Association clearly met the criteria of a medicine related crime but since the maximum sentence for this kind of crime was one year’s imprisonment, its statutory limitation 2 years, the Agency would undertake no action. In its final statement the National Agency for Medicine admonishes Orion and hopes that corresponding acts would not be repeated.
The National agency for Medicine’s investigation was conducted at a time when the World Skiing Championships had just been arranged in the town of Lahti. The Championships ended with six Finnish skiers failing doping tests. There has been heated debate over the Ski association’s actions ever since. It has been made clear to the layman, too, that skiers had in all probability used EPO hormones which covered up the use of plasma enhancers, among other things. It was the plasma enhancer by the name of Hemohes which led to the downfall of the Finnish skiers. What is surprising about the interpretation of the National Agency for Medicine is the fact that despite the Ski Association debate having shaken the whole country and the already declared medicine based crime by Orion, the National Agency decided not to pursue the investigation. Neither has there been a police inquiry into the matter. The National Agency for Medicine’s investigation was restricted to the request for explanation made to Orion alone. Although Orion was guilty of a medicine related crime its explanation was not questioned. It is difficult to imagine that in any so-called normal criminal investigation the only explanation would be from the party suspected of a crime. If that were the case numerous crimes, including fraud and economic crimes would have remained unexplained.
In our opinion it should have been the responsibility of the National Agency for Medicine together with the Police to clarify at least the following questions:
- Has Orion manufactured and/or delivered other medicinal substances for use by the Ski Association? If it has, what and how much?
- Has Orion also supplied the Ski Association with the Company’s EPO and Espander plasma enhancer?
- For what purpose has 10% Ringerster been manufactured for the Ski Association? Has it also been made to test for a covering substance for EPA or some other medicine or drug?
- Why was the supply of Ringerster to the Ski Association in 1998 (a police investigation would have uncovered that, according to the Ski Associations Annual Report cooperation with the ski Association had ended only in 2000 – although Orion claims otherwise)?
- Has the use of 10% Ringerster cause health problems to its users, and has the substance been provided for the use of the under-aged (e.g. to representatives of the junior team)? (In such possible cases the statutory limitation would have been longer and then the crime would not yet have been old in 2001)
In our opinion the investigation should also have heard from representatives of the Finnish Ski Association, informants as well as other interested parties and others involved. A Police-led investigation would have uncovered whether medicine related offences were also connected with serious doping crimes (the 2001 doping offences belonged came under the scope of medicine offences and in some cases drug offences) when at their longest the statutory limitation would have been 20 years (serious drug offences). This would mean that a crime’s statutory limitation involving the Orion case would not yet have been reached.
The Ministry of Social affairs and Health monitors the activities of FIMEA (formerly the National Agency for Medicine). According to the Ministry of Social Affairs and Health’s surveillance unit no real set of rules were given for the FIMEA investigation procedure. The basis on the examination has always been the explanation given by pharmaceutical company, after which the FIMEA can itself decide how it proceeds with the matter. According to the Ministry of Social Affairs and Health the sanctions for false information are heavy for which reason they believed the pharmaceutical company’s explanation. The Police should be informed of a medicine related crime, according to the Ministry of Social Affairs and Health, but this does not apply to old medicine related crimes or suspected crimes provided the FIMEA does not deem it necessary.
The practice has not significantly changed since 2001 nor since the National Agency for Medicine became FIMEA.
Then Orion case shows that there are serious failings in the functioning of the system. It lacks clear guidelines and in some cases investigations possibly lack professional skill. Neither is there enough cooperation with the Police. Cooperation between actors for FIMEA and the National Agency for Medicine is close and therefore gives rise to the question of credibility and to whether an investigation should always include an outside investigator.
We suggest that FIMEA’s role in the investigation of medicine related crimes should be changed and clarified as follows:
- There should be clear procedures for criminal suspicion.
- An investigation should always include an outside investigator from the Police, who, together with FIMEA experts decide whether the case should be taken under police investigation.
- The investigation of a suspected medicine related crime should not be restricted to the request for a clarification by the suspected party
- In connection with the declaration of a medicine related crime’s having become old other possible crimes should be investigated including older offences. The cases should be taken for police investigation without exception.
Possible credibility issues between investigators should be examined in connection with the case.
The pharmaceutical industry, criminality and doping are unfortunately often connected. International doping research continuously uncovers medicine related crimes in different parts of the world. Even before the obtaining of medical certificate from the pharmaceutical industry medicinal substances are used in doping. In many cases substances used in doping are manufactured are used in doping above and beyond medicinal needs. Inadequate cooperation between official responsible for monitoring is also taken advantage of in the production and dissemination of doping. For this reason the professionalism and incorruptibility of the monitoring system are the real basis for rooting out doping offences and naturally for the observation of medicine related crimes.
We hope that you, Minister Paula Risikko correct the observed deficiencies and put the pharmaceutical monitory system on sustainable basis.
Film Director / Film Producer
Arto Halonen / Art Films production AFP Oy
00150 Helsinki, Finland
Tel. +358 9 4159 3640
Reference: Related to When Heroes Lies background material: Orion-reportage