Poland makes patients wait longest in EU for new drugs

By Peter Chapman

Date: 18/11/04

POLISH patients have to wait the longest in the European Union for access to newly approved medicines, a confidential drugs-industry study reveals.

The report, by health data firm IMS, calculated the amount of time it takes for state authorities to agree a price with industry and also the amount that they, or compulsory insurance schemes, will reimburse patients for using the new drugs.

Poland, "where no new, innovative products have been approved for reimbursement for the past six years", tops the list.

Next comes Greece, with an average of 515 days, Slovakia (492 days), Belgium (482), France (457) and the Czech Republic (384).

Best performing between 31 December 1999 and 31 December 2003 are Estonia (97), Austria (81), Germany and the UK (both with zero delays).

Drugs companies rely on speedy decisions in order to recoup as much money as they can for developing their new products during their ten-year patent protection period.

After this time, the price they receive will come down because generic medicine producers are allowed to compete.

Rich citizens have long been able to buy drugs over the internet or through the 'grey market' for whatever the going rate is.

However, the report shows that the pharmaceuticals giants have to contend with long delays across the Union for mainstream access to the latest drugs.

Christophe de Callatay, a spokesman for the European Federation of Pharmaceuticals Industries and Associations (EFPIA), said that for the industry one of the priorities was "to speed up market access".

Delays can make huge inroads into the profitability of specific drugs, depending on the markets involved, he explained.

The IMS study shows that member states continue to procrastinate - even though they have already agreed on the need to speed up access to new medicines as part of the recent 'G10' discussions with industry bosses and the European Commission.

De Callatay pointed out the data do not show the generosity of approved prices or reimbursement.

For example some health authorities, such as the UK's National Health Service, are under pressure to restrict the number of prescriptions made to patients for the most expensive drugs where alternatives are available.

The drugs industry has been involved in a legal dispute with Polish authorities over its alleged circumvention of state controls on marketing activities.

Polish rules on pricing restricted the wholesale margin on pharmaceuticals to 11% - a move designed to keep a lid on huge health charges in the cash-strapped new member state.

For years, the international companies transferred credits to their Polish subsidiaries to subsidize marketing and distribution.

But in 2001, the Polish authorities ruled that the credits were not permitted and that the companies owed excess margins, unpaid VAT and fines.

Around 100 legal cases are pending against importers of pharmaceuticals, with potential fines estimated at between €250 million and €1 billion.

EFPIA is concerned that once the authorities calculate the level of allegedly unpaid tax and fines, the companies might have to make provisions and inform investors on the New York and London stock exchanges.

The industry has called for arbitration on the issue.

Firms have also drafted in the help of Günter Verheugen, the outgoing commissioner for EU enlargement, and the Council of Ministers.

Polish officials were unable to comment on the issue.

Lobbyists for generic medicine manufacturers said that the IMS report was part of a 'big pharma' strategy of attacking the reimbursement system so that, one day, they would be able to charge whatever they like for their products - as they do in the US.

"The only thing is," said one Brussels source, "European governments and citizens are not prepared to accept that."

According to a study by health data firm IMS, Polish patients have to wait the longest in the European Union for access to newly approved medicines. The report calculates the amount of time it takes for state authorities to agree a price with industry and also the amount that they, or compulsory insurance schemes, will reimburse patients for using the new drugs.