E-DRUG: new Polish drug law favours generics?
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[copied from Pharm-Policy with thanks;
http://www.wbj.pl/common/article.asp?id=127334&site=2
copied as fair use. NN]
Pharmaceutical companies wary of pre-EU legal loopholes
By Greg Goodale
Photo: Robert Wojcik
Section: List story
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.
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