Wednesday, October 01, 2008

Polish anti-corruption body highlights problems with 2007 reimbursement list

Following a long investigation, the Polish anti-corruption office (CBA) has reported a number of anomalies related to the inclusion of certain medicines in the human drugs reimbursement list, which was published by the Polish health ministry in November 2007.

The CBA investigation started at the beginning of 2008, after a series of articles in the Polish press questioning the way in which ivabradine, manufactured by French pharmaceutical company Servier, was added to the list (see EURALex, Issue No 189).

The press suggested that ivabradine - a drug used in the treatment of ischaemic heart disease - was included in the November 2007 list following a meeting at the health ministry between then-deputy health minister Boleslaw Piecha and Servier's representatives. The drug was first included in the draft reimbursement list, from which it was removed after a period of public consultation. The press claimed that the drug appeared again on the list after Mr Piecha's meeting with the company's representatives, when the final list was already signed by then-health minister Zbigniew Religa and was awaiting the signature of the finance minister.

Both Mr Piecha and the company denied corruption allegations. In its latest statement on ivabradine, Servier Poland says that the drug was not a last-minute addition to the list, but rather a result of 20 months of consultation process followed by the company's application to include it in the reimbursement list, submitted to the health ministry in March 2006. "Servier fulfilled all the requirements pertaining to the drug's inclusion in the reimbursement list and provided all the necessary information, including the results of studies and opinions," the company maintains.

According to CBA investigators, the documentation pertaining to the reimbursement list refers to a positive recommendation offered for the drug by the ministry's drugs policy department, but in fact this recommendation was never made. The CBA also established that the health minister - who signs the final list - did not receive full information on the costs of ivabradine's inclusion in the list. The CBA claims that the drug policy department estimated ivabradine's reimbursement costs at PLN240 million (Euros70.9 million) per annum, however, the figure provided for in the documentation accompanying the draft reimbursement list was PLN7.8 million. In addition, the CBA also highlighted the lack of mechanisms that would allow the health ministry to carry out an appropriate pharmaco-economic assessment of innovative drugs.

On the other hand, in a report issued a few months ago, the Polish Supreme Chamber of Control (NIK) - a top audit institution overseeing economic efficiency in public spending - offered a positive assessment of the ministry's work on the November reimbursement list, although it, too, pointed out to various abnormalities. The Chamber stressed that Mr Piecha - from a formal point of view and in line with the current legislation - did not exceed his competencies as the deputy health minister responsible for the formation of the list, when he decided to include ivabradine - and two other drugs - without having a positive recommendation from the drugs policy department. The NIK noted, however, that such a practice gives evidence to the lack of transparency, as provided for in the EU Transparency Directive. The NIK report makes several recommendations to the ministry to revise the current legislation governing the reimbursement of medicines to make the process more transparent.

In the meantime, the CBA has forwarded the results of its investigation to the Prosecutor's Office, which has been conducting its own investigation into the offering and receiving of financial benefits related to the inclusion of ivabradine in the reimbursement list. The investigation will also focus on the actions of Mr Piecha.