A dangerous concoction
The list includes around 15,000 drugs, many of which had not legally been filed for registration when included in the annex, others of which have not been properly verified for safety and effectiveness, and some of which are generic copies of originals still under European patent or data protection laws.
While drugs registered under the EU system may be sold throughout the Union, it will not be possible to sell those registered only in the Polish system in the EU after May 1, unless they are named on a list of drugs compiled by the government. These chosen drugs may continue to be sold on the domestic market until upgraded, thus gaining extra time to register them in accordance with EU standards.
The list was drawn up as a result of Poland's insistence that, although this country has been preparing for compliance with European Union law for ten years, many domestically registered drugs may still not have enough time to re-register under EU safety and effectiveness standards before May 1. It was thus agreed that Poland's annex to the accession treaty would include, through consultation with professionals, a list of those medicines which would be allowed to remain on the domestic market until 2008, thus gaining an extra four years in which to re-register according to the new standards. It was agreed that any registration application on the list would have to be filed before October 2002.
Despite the fact that it was consulted with pharmaceuticals companies, the final list was not made publicly available until February last year, when it started to veer markedly from the understanding of the previous negotiations between the government and the EU. Many of the generic drug profiles included were 'ghost products' which had not, in fact, been submitted for registration before October 2002 or for which documentation was missing. Upgrade dates for drugs were inexplicably varied. And some generic applications breached the data exclusivity rights of the originals. As the then president of the Association of Pharmaceutical Companies Representatives in Poland (SPFFP), Jerzy Stęczniewski, wrote in a letter to the European Commission in March last year, this means that the market authorization holders of such drugs, '...were offered other, more favorable terms concerning trade in therapeutic products after Poland's accession to the European Union than other entities involved, which constitutes a violation of the principle of equality before the law, a foremost principle in the constitutions of both the Republic of Poland and the European Union as well.'
The transitional agreement was limited to issues of safety and effectiveness, and did not relate to issues of intellectual property rights. The Pan-European Regulatory Forum issued a clear statement on phasing-in issues, in which it stated that, 'nationally authorized generic versions of centrally approved products cannot stay on the market in candidate countries after accession.' Yet the transition list includes marketing authorizations for drugs which are generic forms of innovative drugs centrally registered in Europe, despite the fact that under European law, generic copies of centrally registered drugs can only be registered in the same central European registry office. Moreover, ten year data exclusivity rights for centrally registered drugs were introduced in 1995, which means that no generic copies of such drugs are yet legal on the EU market.
The list includes marketing authorizations of two domestic generic producers, Polpharma and Polfa Pabianice, as well as Croatian producer Pliva, for generic copies of Pfizer's blockbuster drug Viagra, which is centrally registered in the EU and still under data exclusivity protection. Also on the transitional list is the marketing authorization of another local generic producer, Adamed, for a generic copy of Eli Lilly's centrally registered schitzophrenia drug, Zyprexa. And Adamed's generic copy of Zyprexa, despite somewhat less than universal faith in its effectiveness, is also included on the government's list of reimbursed medicines.
Until Poland joins the EU in May, data exclusivity rights last only three years on the domestic market, in accordance with Polish law. The inclusion of generic copies of centrally registered drugs on the list, therefore, can only be seen as either a mistake, or an attempt on the part of the compilers of the transitional list to obtain remission from European data protection laws, for the marketing authority holders of such generic copies. As Brian Ager, Director General of the European Federation of Pharmaceutical Industries and Associations wrote to the Director of the European Commission DG Enterprise, Paul Weissenberg: 'The illegitimate inclusion of such products would severely undermine EU pharmaceutical law and in particular the status of the EU's centralized procedure.'
No government ministry or official body is willing to claim responsibility for the list, though two ministries have expressly denied responsibility, so that the public still has no official knowledge as to who exactly compiled it. Yet findings revealed this January of an investigation into the drug registry proceedings under former Health Minister Łapiński show that, during his term of office, many applications were hurried through the system without proper verification procedures. Some, for example, were registered just two weeks after filing applications (a process which normally takes up to two years) - a worrying fact for consumers as well as for the registration office's reputation, considering that these drugs will be available on the market.
The European Commission (EC) has made clear its position in a letter to the SPFFP, stating that, 'If a product does not exist or has been unlawfully registered it cannot acquire any rights from being listed in the appendix.'
Until May, however, the Commission can not take any action in Poland to enforce this statement.
According to Paulina Kieszkowska, legal expert at international law firm Baker & McKenzie, for the moment, the EU's position, though clear, is of little practical use either for consumer safety or for the producers whose legal and commercial interests will be damaged by the list, since until May the Commission cannot take any effective legal action against Poland for violations of the accession treaty. Legal procedures open to those companies whose legal and commercial interests are threatened by this list will have to begin in the domestic courts, which are not versed in European Law. Such legal procedures are also constantly delayed and blocked by the authorities, so that several years could well pass before any cases are settled.
"The only thing would be for the Commission to sue Poland for abuse of the accession treaty," she says.
For the moment, the Commission spokesman has this to say:
"We are likely to present a communication shortly providing guidance for how member states should be applying the regulatory framework for pharmaceuticals on their markets."
As to what the final outcome will be, only time will tell.
The Ministry of Health and the Drugs Registry Office were unavailable for comment.
While drugs registered under the EU system may be sold throughout the Union, it will not be possible to sell those registered only in the Polish system in the EU after May 1, unless they are named on a list of drugs compiled by the government. These chosen drugs may continue to be sold on the domestic market until upgraded, thus gaining extra time to register them in accordance with EU standards.
The list was drawn up as a result of Poland's insistence that, although this country has been preparing for compliance with European Union law for ten years, many domestically registered drugs may still not have enough time to re-register under EU safety and effectiveness standards before May 1. It was thus agreed that Poland's annex to the accession treaty would include, through consultation with professionals, a list of those medicines which would be allowed to remain on the domestic market until 2008, thus gaining an extra four years in which to re-register according to the new standards. It was agreed that any registration application on the list would have to be filed before October 2002.
Despite the fact that it was consulted with pharmaceuticals companies, the final list was not made publicly available until February last year, when it started to veer markedly from the understanding of the previous negotiations between the government and the EU. Many of the generic drug profiles included were 'ghost products' which had not, in fact, been submitted for registration before October 2002 or for which documentation was missing. Upgrade dates for drugs were inexplicably varied. And some generic applications breached the data exclusivity rights of the originals. As the then president of the Association of Pharmaceutical Companies Representatives in Poland (SPFFP), Jerzy Stęczniewski, wrote in a letter to the European Commission in March last year, this means that the market authorization holders of such drugs, '...were offered other, more favorable terms concerning trade in therapeutic products after Poland's accession to the European Union than other entities involved, which constitutes a violation of the principle of equality before the law, a foremost principle in the constitutions of both the Republic of Poland and the European Union as well.'
The transitional agreement was limited to issues of safety and effectiveness, and did not relate to issues of intellectual property rights. The Pan-European Regulatory Forum issued a clear statement on phasing-in issues, in which it stated that, 'nationally authorized generic versions of centrally approved products cannot stay on the market in candidate countries after accession.' Yet the transition list includes marketing authorizations for drugs which are generic forms of innovative drugs centrally registered in Europe, despite the fact that under European law, generic copies of centrally registered drugs can only be registered in the same central European registry office. Moreover, ten year data exclusivity rights for centrally registered drugs were introduced in 1995, which means that no generic copies of such drugs are yet legal on the EU market.
The list includes marketing authorizations of two domestic generic producers, Polpharma and Polfa Pabianice, as well as Croatian producer Pliva, for generic copies of Pfizer's blockbuster drug Viagra, which is centrally registered in the EU and still under data exclusivity protection. Also on the transitional list is the marketing authorization of another local generic producer, Adamed, for a generic copy of Eli Lilly's centrally registered schitzophrenia drug, Zyprexa. And Adamed's generic copy of Zyprexa, despite somewhat less than universal faith in its effectiveness, is also included on the government's list of reimbursed medicines.
Until Poland joins the EU in May, data exclusivity rights last only three years on the domestic market, in accordance with Polish law. The inclusion of generic copies of centrally registered drugs on the list, therefore, can only be seen as either a mistake, or an attempt on the part of the compilers of the transitional list to obtain remission from European data protection laws, for the marketing authority holders of such generic copies. As Brian Ager, Director General of the European Federation of Pharmaceutical Industries and Associations wrote to the Director of the European Commission DG Enterprise, Paul Weissenberg: 'The illegitimate inclusion of such products would severely undermine EU pharmaceutical law and in particular the status of the EU's centralized procedure.'
No government ministry or official body is willing to claim responsibility for the list, though two ministries have expressly denied responsibility, so that the public still has no official knowledge as to who exactly compiled it. Yet findings revealed this January of an investigation into the drug registry proceedings under former Health Minister Łapiński show that, during his term of office, many applications were hurried through the system without proper verification procedures. Some, for example, were registered just two weeks after filing applications (a process which normally takes up to two years) - a worrying fact for consumers as well as for the registration office's reputation, considering that these drugs will be available on the market.
The European Commission (EC) has made clear its position in a letter to the SPFFP, stating that, 'If a product does not exist or has been unlawfully registered it cannot acquire any rights from being listed in the appendix.'
Until May, however, the Commission can not take any action in Poland to enforce this statement.
According to Paulina Kieszkowska, legal expert at international law firm Baker & McKenzie, for the moment, the EU's position, though clear, is of little practical use either for consumer safety or for the producers whose legal and commercial interests will be damaged by the list, since until May the Commission cannot take any effective legal action against Poland for violations of the accession treaty. Legal procedures open to those companies whose legal and commercial interests are threatened by this list will have to begin in the domestic courts, which are not versed in European Law. Such legal procedures are also constantly delayed and blocked by the authorities, so that several years could well pass before any cases are settled.
"The only thing would be for the Commission to sue Poland for abuse of the accession treaty," she says.
For the moment, the Commission spokesman has this to say:
"We are likely to present a communication shortly providing guidance for how member states should be applying the regulatory framework for pharmaceuticals on their markets."
As to what the final outcome will be, only time will tell.
The Ministry of Health and the Drugs Registry Office were unavailable for comment.
