Drugmakers lobby to cut red tape

Over-the-counter (OTC) drugmakers are calling on the government to streamline registration procedures for their products, saying that by relaxing industry regulations the state would also benefit through decreased strain on the public healthcare sector. Ten leading non-prescription drug producers announced last week they had formed a lobby organization called the Polish Association of the Self-Medication Industry (PASMI) to promote their products within the government and the medical industry. PASMI is hoping other pharmaceutical companies will join the group soon. "We want simpler procedures for clearing OTC drugs for the market," said Jacek Wźgrzyk, president of PASMI. PASMI is the Polish arm of the Association of European Self-Medication Industry (AESGP), based in Brussels. "The system of marketing authorization should be improved, that is streamlined, (be made) more coherent and more transparent," said Hubertus Cranz, general director of AESGP, referring to government-granted market clearance. "There are too many unnecessary bureaucratic burdens now, while there is no need to provide all kinds of documentation, such as for chamomile or peppermint tea, which are commonly recognized as healthy products." According to Cranz, the present system also permits discriminatory treatment of drugmakers. "Sometimes the results (of clearance procedures) vary within similar products," he said, adding that these procedures should be made shorter and more predictable. Industry insider opinions were mixed, however, on the likelihood that OTC-drug clearance procedures would be simplified in the near future. A new pharmaceutical law that takes effect April 1 may lead to clearer registration procedures because it mandates the creation of an Office for Drug Registration (URL), according to Stefan Bogusławski, president of AzyX Polska, which monitors the Polish drug market. "This body is much needed, as its task will be to set up uniform procedures for drug recognition," Bogusławski said. But Bogusław Taźbirek, a drug industry analyst at PBK Asset Management, said major improvements in registration procedures are unlikely. "I'm afraid we will still live with a mass of discretional decisions that are up to the mood of some Pani Bureaucrat," he said. "Licenses are the wind in the sails of officials, who feel important thanks to them." According to PASMI representatives, the increasing use of non-prescription drugs can help reduce the mounting burden on the public healthcare system, as minor ailments don't require a visit to a doctor. "If patients go straight to a pharmacy to buy the drug they need, it relieves doctors, who can then concentrate on more serious cases," Wźgrzyk said. "This trend may have a positive impact on the state budget in a few years." Sales of OTC drugs sold in Poland have risen four-fold from 1994 to 2001, surging 18% last year, according to PASMI. The share of OTC drugs comprised 26.7% of all pharmaceutical sales in Poland last year, according to AzyX Geopharma Information Services. Drug registration authorities were unavailable for comment on the lobbying group's proposal.