Pharmaceutical companies wary of pre-EU legal loopholes
Changing times: a new pharmaceutical law stands to give generic makers an unfair advantage.
Pharmaceutical companies are concerned that the current draft of Poland's new Pharmaceutical Law designed to bring the country in line with the European Union (EU) breaks the terms of the country's World Trade Organization (WTO) membership and reduces their intellectual property rights, giving generic drug manufacturers an unfair advantage.
The new law, due to come into force Jan. 1, gives patent holders no data exclusivity period (an additional form of intellectual property protection), which would greatly shorten the time needed to bring a generic drug to the market.
"This will mean that any company can get the dossiers of any R&D-based company's products, copy them and bring them to market without any problem," said Cees Heiman, country manager of Pfizer Polska.
After a patent has been granted a research extension, the originator is required to demonstrate that the drug is safe before obtaining permission from the Bureau of Drugs and Medical Materials Registration (BRSFMM) to sell the substance. To allow patent owners to recoup some of their research and development costs, there is a period of time after the granting of a patent when every applicant that wishes to market a generic version of the drug must carry out their own tests for the approval procedure. This is termed the exclusivity period. Once this has expired, generic manufacturers do not need to submit toxicological, pharmacological or clinical tests as long as the drug has the same composition as a pharmaceutical already registered in Poland. In 1993 a Health Ministry ordnance allowed applicants to submit a limited dossier of tests after just three years.
The draft Pharmaceutical Law was passed by the Sejm with strong bilateral support on July 27 and is being debated and voted on by the Senate this month. It states that a six-year data exclusivity period will become law once Poland becomes an EU member. But its enabling law states that until that time applicants wishing to market a patented drug do not have to repeat the BRSFMM tests, as long as the product is similar to an already authorized product. Any drugs that have an expired Polish patent and receive marketing approval next year can be manufactured in generic form in competition with the originator's products, but at a lower cost since generic manufacturers do not need to cover the drug's R&D or marketing research costs.
The most negatively effected drugs will be those patented before 1993, which were only protected by patents for 15 years. Because obtaining marketing approval procedures for these drugs may have taken the full length of the patent, this means that any pharmaceuticals that receive BRSFMM approval next year can be launched by generic manufacturers shortly after their originators. According to Heiman, this will put companies investing in R&D at a disadvantage, and will affect their willingness to launch new drugs before EU accession. "This legislation could potentially limit access to new modern drugs for the Polish population, for the simple reason that many foreign companies would ask themselves why they should jeopardize bringing new molecules to the market when they can be copied without any legal property protection."
According to Jolanta Sabbat, head of the EU integration committee at the Association of Representatives of the Polish Pharmaceuticals Market (SPPRF), the law will contravene two major international agreements to which Poland is a party: the Trade Related Intellectual Property agreement (TRIPs), which must be signed by all members of the World Trade Organization (WTO), and the Europe Agreement, a pre-accession agreement signed by Poland in 1991. "Article 3 of the law infringes the Europe Agreement in article 66 and infringes article 39.3 of TRIPs, of which Poland is a signatory," Sabbat said. She added that by signing the Europe Agreement, Poland agreed to adopt similar levels of commercial property rights as the EU five years prior to accession, while TRIPs binds signatories to protect intellectual property against unfair commercial use when research into the data involves considerable effort. The Health Ministry refused to comment last week as the enabling law is still in draft form.
Andrzej Furman, chairman of pharmaceutical manufacturer PPH Aflopa, said it was unlikely that generic manufacturers would profit if exclusivity periods were removed. He said the period between the implementation of the law and EU accession would not give generic manufacturers enough time to get marketing permits from the BRSFMM.
"The process of bringing drugs onto the market doesn't allow you to start production one day and sell them the next," he said. "The registration process in Poland is very lengthy, sometimes more than two years."
Polfarmed, the association of Polish pharmaceutical distributors and manufacturers, was unavailable for comment at press time.
