Reckoning time for pharmaceuticals
For years, the Polish government has tried to benefit from the R&D investments of innovative pharmaceutical companies without having to pay for them, by pursuing a reimbursement policy which illegally favors generics, even to the extent of allowing suspicious registrations and overlooking patent infringements, say international lawyers. And since the Polish government has so far shown no eagerness to either rethink its policy, or even confine it within the restraints of EU law, Poland's EU entry could herald a very litigious season in pharmaceuticals. Growing tensions between the government and the European Commission over the Ministry of Health could also mean that, if all else fails, the government may soon find it has brought EU sanctions upon itself, adding to its growing portfolio of woes.
As the EFPIA (European Federation of Pharmaceutical Industries) recently noted in its Poland report, innovative companies are effectively excluded from consideration in reimbursement decisions. No new original drugs have been included on the reimbursement list for six years, and many applications examined by the EFPIA had not even been processed. Both are issues that could be addressed under a wide section of EU legislation.
But the biggest storm on the horizon concerns the notorious 'transition list' that Poland - uniquely - negotiated into its accession treaty, a list of locally registered drugs that can still be sold on the domestic market until 2008, even if they don't upgrade to EU registration standards before that date. The government has somehow managed to slip into this list copies of drugs that are centrally registered within the EU, and since, under EU law, copies of centrally registered drugs must also be centrally registered then, according to statements from the Commission, it follows that such drugs cannot be legally sold.
T
hough most of these drugs have not yet even completed their local registration process, and so cannot be sold yet anyway, at least one of these drugs, known as 'Zolafren,' marketed by local generic company Adamed, is already on the market. With a matter of days to go before EU entry, the drug is still being refunded by the government as a therapeutic equivalent to Eli Lilly's original schizophrenia therapy 'Zyprexa,' despite an ongoing legal battle regarding an alleged local patent infringement and doubts as to its actual clinical credentials.
Over the past year, rising tensions between the government and the European Commission on this issue have made the case symbolic of this country's criminal attitude towards research and development in pharmaceuticals. So much so that, after May 1, an unholy row looks very much in sight.
According to Paulina Kieszkowska, legal expert at international lawyers Baker and McKenzie, "The government has, so far, shown no signs of withdrawing it."
Meanwhile, Maciej Adamkiewicz, CEO of Adamed, is confident that Zolafren will remain on the reimbursement list after May 1. "Since the drug is on the transition list, there is no need to take it off the market," he says, adding "The drug was registered in Poland before Poland joined the EU, and EU law cannot work retrospectively."
Yet, according to Andras Fehervary, Eli Lilly's corporate director for this region, "The Commission has been clear and unequivocal that Zolafren will have to come off the market on May 1." And international lawyers agree with Paulina Kieszkowska's view that legally, it could lead to sanctions.
Politically though, some suspect that this may not actually happen, one sign being that despite the European Commission's repeated warnings over the last year that it is about to issue a communication on the matter, the communication has - so far - yet to come.
Agnieszka Deeg-Dąbrowska, who acted for Eli Lilly on the Zyprexa-Zolafren case, was unwilling to discuss the matter directly, but was nevertheless prepared to comment on the general situation. She suggests that rather than bringing issues to a head with a flood of legal cases, EU entry could actually see a relaxation of tensions.
"It seems to me that innovative companies are now evaluating their position," she says, going on to suggest that many companies might try to make constructive use of the new clout afforded them by access to EU legislation.
"Pharmaceutical companies might go with some kind of compromise," she suggests, "and, for example, abandon legal proceedings if the government fully implements EU Directives and Regulations."
But such a possibility, she adds, would obviously be dependent on the government's willingness to turn over a new leaf. "There is no consciousness in Poland that copying drugs is illegal," she says, adding that the general population doesn't understand that innovative companies won't create new drugs unless they have some incentive, or appreciate the value and expense of clinical trials. She points to a prevalent 'Robin Hood' approach that glorifies the stealing of intellectual property in pharmaceuticals.
Court proceedings initiated by innovative companies are, according to Paulina Kiesz-kowska, constantly frustrated and obstructed, she says, while the press has shown no interest in the issue, either. Her repeated memorandums to newpapers on everything from suspicious generic registrations to the sinister trampling of intellectual property rights have consistently aroused no interest, she asserts, even though Zolafren, for example, affects 40,000 people.
Whether the prevailing culture will be able to turn its mentality around soon enough to avoid a clash seems highly unlikely, given the evidence. Meanwhile, however keen the European Commission may be to avoid a political fiasco, Paulina Kieszkowska believes there is simply no other way out of this particular situation, unless the drug comes off the market.
"The Commission simply cannot let a generic copy of a centrally registered product be sold within the EU without correct documentation," she says.
The Ministry of Health press spokesperson did not reply to our questions.
As the EFPIA (European Federation of Pharmaceutical Industries) recently noted in its Poland report, innovative companies are effectively excluded from consideration in reimbursement decisions. No new original drugs have been included on the reimbursement list for six years, and many applications examined by the EFPIA had not even been processed. Both are issues that could be addressed under a wide section of EU legislation.
But the biggest storm on the horizon concerns the notorious 'transition list' that Poland - uniquely - negotiated into its accession treaty, a list of locally registered drugs that can still be sold on the domestic market until 2008, even if they don't upgrade to EU registration standards before that date. The government has somehow managed to slip into this list copies of drugs that are centrally registered within the EU, and since, under EU law, copies of centrally registered drugs must also be centrally registered then, according to statements from the Commission, it follows that such drugs cannot be legally sold.
T
hough most of these drugs have not yet even completed their local registration process, and so cannot be sold yet anyway, at least one of these drugs, known as 'Zolafren,' marketed by local generic company Adamed, is already on the market. With a matter of days to go before EU entry, the drug is still being refunded by the government as a therapeutic equivalent to Eli Lilly's original schizophrenia therapy 'Zyprexa,' despite an ongoing legal battle regarding an alleged local patent infringement and doubts as to its actual clinical credentials.
Over the past year, rising tensions between the government and the European Commission on this issue have made the case symbolic of this country's criminal attitude towards research and development in pharmaceuticals. So much so that, after May 1, an unholy row looks very much in sight.
According to Paulina Kieszkowska, legal expert at international lawyers Baker and McKenzie, "The government has, so far, shown no signs of withdrawing it."
Meanwhile, Maciej Adamkiewicz, CEO of Adamed, is confident that Zolafren will remain on the reimbursement list after May 1. "Since the drug is on the transition list, there is no need to take it off the market," he says, adding "The drug was registered in Poland before Poland joined the EU, and EU law cannot work retrospectively."
Yet, according to Andras Fehervary, Eli Lilly's corporate director for this region, "The Commission has been clear and unequivocal that Zolafren will have to come off the market on May 1." And international lawyers agree with Paulina Kieszkowska's view that legally, it could lead to sanctions.
Politically though, some suspect that this may not actually happen, one sign being that despite the European Commission's repeated warnings over the last year that it is about to issue a communication on the matter, the communication has - so far - yet to come.
Agnieszka Deeg-Dąbrowska, who acted for Eli Lilly on the Zyprexa-Zolafren case, was unwilling to discuss the matter directly, but was nevertheless prepared to comment on the general situation. She suggests that rather than bringing issues to a head with a flood of legal cases, EU entry could actually see a relaxation of tensions.
"It seems to me that innovative companies are now evaluating their position," she says, going on to suggest that many companies might try to make constructive use of the new clout afforded them by access to EU legislation.
"Pharmaceutical companies might go with some kind of compromise," she suggests, "and, for example, abandon legal proceedings if the government fully implements EU Directives and Regulations."
But such a possibility, she adds, would obviously be dependent on the government's willingness to turn over a new leaf. "There is no consciousness in Poland that copying drugs is illegal," she says, adding that the general population doesn't understand that innovative companies won't create new drugs unless they have some incentive, or appreciate the value and expense of clinical trials. She points to a prevalent 'Robin Hood' approach that glorifies the stealing of intellectual property in pharmaceuticals.
Court proceedings initiated by innovative companies are, according to Paulina Kiesz-kowska, constantly frustrated and obstructed, she says, while the press has shown no interest in the issue, either. Her repeated memorandums to newpapers on everything from suspicious generic registrations to the sinister trampling of intellectual property rights have consistently aroused no interest, she asserts, even though Zolafren, for example, affects 40,000 people.
Whether the prevailing culture will be able to turn its mentality around soon enough to avoid a clash seems highly unlikely, given the evidence. Meanwhile, however keen the European Commission may be to avoid a political fiasco, Paulina Kieszkowska believes there is simply no other way out of this particular situation, unless the drug comes off the market.
"The Commission simply cannot let a generic copy of a centrally registered product be sold within the EU without correct documentation," she says.
The Ministry of Health press spokesperson did not reply to our questions.
