Government game of doctors and nurses could soon be up
The move is another frightening step in a policy which represents a cynical disregard for the health and safety of citizens in the interest of short-term budget gains, say doctors. Such arbitrary recommendations have no standing in Polish law, let alone EU legislation, say lawyers. Yet the government is still going ahead with its plans, anyway.
The drugs reimbursement list in this country is organized into therapeutic categories where the cheapest product in the group defines the reimbursement limit. Decisions as to which drugs are included, as well as what the reimbursement levels are, constitute a legislative act by the minister of health, thus making any appeals against government decisions impossible unless they go before the Constitutional Tribunal.
As the most recent monitoring report by the European Federation of Pharmaceutical Industry Associates (EFPIA) highlights, such a set up is dangerous in the area of refunded pharmaceuticals, where the government is, after all, not a disinterested body, but one of the interested parties.
"Unless there are specific criteria for decision making, and mechanisms enabling either patients or affected pharmaceutical companies to challenge such decisions," points out Paulina Kieszkowska, an international lawyer at Baker and McKenzie, "legally there's nothing effectively stopping the government from following discriminatory policies or putting short-term budgets needs before the health of citizens."
The new pricing recommendations, according to Paweł Piotrowski, a spokesperson for the Association of Pharmaceutical Representatives (SPFF), have no legal standing: "Members of our Association do not understand declarations of possible changes to the reimbursement rules done in a way of recommendations or guidelines, that have nothing in common with Polish law," he says.
But for the moment, there is precious little that either the SPFF or anyone else can do about this or any of the government's other actions regarding the reimbursement list, as there is no effective judicial remedy available.
The current list includes some generics which have been registered over suspiciously short periods, some which are in short supply and some which have never been tested in 'life-therapy'. The list also includes drugs which are unavailable on the market because they are actually involved in patent infringement cases.
"It's as if the government thinks that it's enough to put a name and a price on the list," says Kieszkowska, "and that issues of whether the products are actually effective, safe or even available are simply disregarded."
She points out that in the EU and the other accessing countries, it is standard practice that drugs, before being included on reimbursement lists, have to be on the market for several months at least so that they get tested in 'life therapy' and not simply undergo clinical trials when registered. Kieszkowska reveals, meanwhile, that, "in this country, a cancer drug with eighteen years proven 'real-life' trial experience was replaced by a drug authorized after just three months in very suspicious circumstances currently subject to criminal investigation, and was then included on the list without any previous life-trial whatsoever."
Furthermore, she says that the inclusion on the list of drugs which are currently involved in cases of patent infringement constitutes not only a disrespect for the law on the part of the government itself, but also a surreal attempt to involve citizens in crime.
"The list includes one drug that, due to court proceedings, is under contingency liability," she says, "which means that selling it is actually illegal."
In her view, it's hard not to interpret the government's practice of adding unavailable drugs to the list as a deliberate attempt to short-change the public. Since the reimbursement level of all drugs is determined by the price of the cheapest product in its category, adding a cheaper product means that the government pays less towards all other drugs in the category.
"And if the new cheaper drug is not at the pharmacy, then patients will be forced to fork out more from their own pockets to get a different drug in the category," Kieszkowska says, pointing out that the difference in price between drugs can be very significant. Canceling reimbursement altogether for drugs costing over 20 percent more than the cheapest will merely intensify the problem.
According to Piotr Zwoliński, president of Neuronet, a foundation supporting epileptics, short-term financial interests mean that the government is cavalier not just about the legal, but also the medical status of refunded therapies.
He points to several cases of drugs being included on the list that demonstrate this, one example being a generic marketed by local pharmaceutical producer Adamed which is suspected of infringing an Elli Lilly patent. Ironically, Adamed, which has failed to provide its drug registration and clinical credentials, defends itself against the patent infringement charges by claiming that its drug is not actually a bio-equivalent of Elli Lilly's Zyprexa after all. "In which case," Zwoliński asks, "why is the drug offered on the list as an alternative?"
Meanwhile, contrary to the message of government propaganda, sensational cost-cutting measures, says Zwoliński, benefit short-term party interests, not the budget. "Non-governmental organizations calculate that we will have to pay an extra zł.80 million in extra-hospitalization fees in 2005 as a direct result of this government's failure to reimburse effective medicines," he states.
However, things could change with Poland's entry to the EU, as it has not gone unnoticed there that this country's system for drug reimbursement is seriously out of line with EU requirements.
"According to EU directive 89/105/EEC, decisions on the price of a medicinal product and its inclusion in the national health insurance system should be timely, transparent and challengeable," says Peter Sandler, press spokesman for the EU Enterprise and Information Agency. And since, as the EFPIA report makes very clear, the current system of reimbursement in Poland does not fulfill any of these criteria, he concludes, "Obviously, once the provisions of the transparency directive are in force in Poland, this could open the possibility for a complaint concerning Polish compliance with Community legislation to the Commission."
If the situation isn't remedied after that, he says, "The most likely outcome, is that the Commission would take Poland to the EU Court of Justice."
Nevertheless, as Norbert Wilk, an official at the Ministry of Health's reimbursement division confirms, the government's newest recommendations are scheduled to come into force in May.
The drugs reimbursement list in this country is organized into therapeutic categories where the cheapest product in the group defines the reimbursement limit. Decisions as to which drugs are included, as well as what the reimbursement levels are, constitute a legislative act by the minister of health, thus making any appeals against government decisions impossible unless they go before the Constitutional Tribunal.
As the most recent monitoring report by the European Federation of Pharmaceutical Industry Associates (EFPIA) highlights, such a set up is dangerous in the area of refunded pharmaceuticals, where the government is, after all, not a disinterested body, but one of the interested parties.
"Unless there are specific criteria for decision making, and mechanisms enabling either patients or affected pharmaceutical companies to challenge such decisions," points out Paulina Kieszkowska, an international lawyer at Baker and McKenzie, "legally there's nothing effectively stopping the government from following discriminatory policies or putting short-term budgets needs before the health of citizens."
The new pricing recommendations, according to Paweł Piotrowski, a spokesperson for the Association of Pharmaceutical Representatives (SPFF), have no legal standing: "Members of our Association do not understand declarations of possible changes to the reimbursement rules done in a way of recommendations or guidelines, that have nothing in common with Polish law," he says.
But for the moment, there is precious little that either the SPFF or anyone else can do about this or any of the government's other actions regarding the reimbursement list, as there is no effective judicial remedy available.
The current list includes some generics which have been registered over suspiciously short periods, some which are in short supply and some which have never been tested in 'life-therapy'. The list also includes drugs which are unavailable on the market because they are actually involved in patent infringement cases.
"It's as if the government thinks that it's enough to put a name and a price on the list," says Kieszkowska, "and that issues of whether the products are actually effective, safe or even available are simply disregarded."
She points out that in the EU and the other accessing countries, it is standard practice that drugs, before being included on reimbursement lists, have to be on the market for several months at least so that they get tested in 'life therapy' and not simply undergo clinical trials when registered. Kieszkowska reveals, meanwhile, that, "in this country, a cancer drug with eighteen years proven 'real-life' trial experience was replaced by a drug authorized after just three months in very suspicious circumstances currently subject to criminal investigation, and was then included on the list without any previous life-trial whatsoever."
Furthermore, she says that the inclusion on the list of drugs which are currently involved in cases of patent infringement constitutes not only a disrespect for the law on the part of the government itself, but also a surreal attempt to involve citizens in crime.
"The list includes one drug that, due to court proceedings, is under contingency liability," she says, "which means that selling it is actually illegal."
In her view, it's hard not to interpret the government's practice of adding unavailable drugs to the list as a deliberate attempt to short-change the public. Since the reimbursement level of all drugs is determined by the price of the cheapest product in its category, adding a cheaper product means that the government pays less towards all other drugs in the category.
"And if the new cheaper drug is not at the pharmacy, then patients will be forced to fork out more from their own pockets to get a different drug in the category," Kieszkowska says, pointing out that the difference in price between drugs can be very significant. Canceling reimbursement altogether for drugs costing over 20 percent more than the cheapest will merely intensify the problem.
According to Piotr Zwoliński, president of Neuronet, a foundation supporting epileptics, short-term financial interests mean that the government is cavalier not just about the legal, but also the medical status of refunded therapies.
He points to several cases of drugs being included on the list that demonstrate this, one example being a generic marketed by local pharmaceutical producer Adamed which is suspected of infringing an Elli Lilly patent. Ironically, Adamed, which has failed to provide its drug registration and clinical credentials, defends itself against the patent infringement charges by claiming that its drug is not actually a bio-equivalent of Elli Lilly's Zyprexa after all. "In which case," Zwoliński asks, "why is the drug offered on the list as an alternative?"
Meanwhile, contrary to the message of government propaganda, sensational cost-cutting measures, says Zwoliński, benefit short-term party interests, not the budget. "Non-governmental organizations calculate that we will have to pay an extra zł.80 million in extra-hospitalization fees in 2005 as a direct result of this government's failure to reimburse effective medicines," he states.
However, things could change with Poland's entry to the EU, as it has not gone unnoticed there that this country's system for drug reimbursement is seriously out of line with EU requirements.
"According to EU directive 89/105/EEC, decisions on the price of a medicinal product and its inclusion in the national health insurance system should be timely, transparent and challengeable," says Peter Sandler, press spokesman for the EU Enterprise and Information Agency. And since, as the EFPIA report makes very clear, the current system of reimbursement in Poland does not fulfill any of these criteria, he concludes, "Obviously, once the provisions of the transparency directive are in force in Poland, this could open the possibility for a complaint concerning Polish compliance with Community legislation to the Commission."
If the situation isn't remedied after that, he says, "The most likely outcome, is that the Commission would take Poland to the EU Court of Justice."
Nevertheless, as Norbert Wilk, an official at the Ministry of Health's reimbursement division confirms, the government's newest recommendations are scheduled to come into force in May.
