Poland to reopen EU chapter for drugs industry
By : Jeffrey Sparshott
Poland this week is expected to ask the European Union (EU) (http://www.europa.eu.int./index_en.htm) to reopen negotiations on the free flow of goods so that domestic pharmaceutical firms can have a transition period for drug registration procedures, Polish negotiators (http://www.negocjacje.gov.pl) said last week.
If there were no transition period, the consequences for the Polish pharmaceuticals industry would be catastrophic, said Wojciech Kumierkiewicz, a vice president of Zakłady Farmaceutyczne Polpharma.
Outside observers saw the move as a setback. To reopen a chapter in order to renegotiate a transition period is not a very positive sign, said Barbara Bättcher, an economist with Deutsche Bank Research. If the other countries have closed this chapter already and Poland is going to renegotiate, theyre one step behind.
Jarosław Pietras, a member of Polands negotiating team, said that if the small technical problem is not resolved, it will have a substantial impact on the pharmaceutical sector. Poland had closed the negotiations without the transition period, which would force Polish drugmakers to register all products according to EU standards immediately on EU accession, rather than waiting until the expiration of currently valid five-year permits.
We would like that process to happen in a more natural manner, Pietras said. Under Polands new stance, current permits would be allowed to run to the end of their five-year term before companies would have to register under the new regime.
They will be registered under different documents, Pietras said. This does not affect quality or substance, just documentation. In essence, we are talking about a medical product that is the same. From the point of view of economics, it is a technical operation.
Foreign pharmaceutical firms were not pleased with the decision.
It means that domestic manufacturers will be able to continue to have marketing authorization for products even if the regulatory data does not meet EU standards of efficacy, safety and quality, said Jolanta Sabbat, head of the EU integration committee for the Association of Representatives of the Polish Pharmaceuticals Market (SPFFwP), whose members include non-Polish firms. This will delay the possibility for those manufacturers who have requested this postponement of EU standards for the registration dossier in accessing EU markets. It may negatively impact their competitiveness in the enlarged EU.
Polish products, which are now three to four times cheaper than EU products, would quickly become more expensive if Poland had to adopt EU rules all at once, said Kumierkiewicz, also vice chairman of Polfarmed (http://www.polfarmed.com.pl), an association of Polish pharmaceutical distributors and manufacturers. He added that EU-member states have been granted internal transition periods to meet EU-wide rules.
The faster we adjust ourselves to the European Union the more expensive pharmaceuticals will become, he said, noting that the consequences would be severe for doctors and patients.
The EU last week did not comment on the news. We have not received a formal request yet by the Poles to reopen the chapter, said Jean-Christophe Filori, the European Commissions spokesman for enlargement. Hence we cannot make any comment for the moment.
Compared with other candidate countries, Poland has not made as much progress in settling the 30 negotiation areas, termed chapters by the EU, which must be solved prior to joining the bloc. Cyprus has provisionally closed 23 chapters, Hungary 22, Slovenia 21, the Czech Republic, Estonia and Slovakia 19 each. Prior to reopening the goods chapter, Poland had wrapped up 17.
For the time being it is certain that they are lagging behind other countries, Bättcher said. It is a rather severe problem for Poland. But we expect substantial changes with the new government. Poland can catch up rather soon.
According to the EUs schedule, all 30 chapters should be concluded by 2003.
Pietras denied that the reopening is a setback for Poland. In this case we are preventing a problem, he said, adding that the latest development was simply a technical issue. The toughest negotiations are still to come.
In the not so distant future we will be facing a number of important problems in important chapters beyond technical issues, he said, noting that discussions between Poland and the EU are constant but any major breakthroughs are unlikely before the Sept. 23 parliamentary elections.
Agriculture, free movement of people, competition policy and land purchases by foreigners are some of the toughest issues Poland faces.
Polands decision to reopen the goods chapter coincided with last Thursdays approval by the Sejm of a new pharmaceuticals law that starts to bring the pharmaceuticals industry, including the drug registration process, in line with European law.
