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Law eases prescription controls

Regulation creates new medicine category, standards for Internet pharmacies

By Victor Velek
Staff Writer, The Prague Post
November 21st, 2007 issue

Jan Přerovský/THE PRAGUE POST
Drugs falling under the new category, while available over the counter, will have individual requirements, like age, for their sale.
In the near future, the quest to purchase medicine in the Czech Republic may become less daunting. As of next year, pharmacies should be able to provide several hundred more over-the-counter drugs, thanks to a new medicine bill passed by the Chamber of Deputies last month.
The new law also regulates the sale of medication over the Internet and implements European Union directives that the Czech Republic has previously failed to adopt — ones that may still result in EU fines. Earlier this year, the country lost two lawsuits for its failure to implement EU directives on medicines.
If the bill is approved by the Senate, which is likely, pharmacies will be able to offer a new category of partially regulated drugs in addition to the two existing categories, prescription drugs and freely sold, over-the-counter drugs.
“[The new] category of drugs will be handed out without prescriptions but under certain limitations,” said Health Ministry spokesman Tomáš Cikrt.
Buyers of medication falling under this category will be required to present ID and meet certain requirements stemming from specifics related to the individual drug — age, for example, in the case of contraception.
Several hundred drugs could be slated for the new category, estimated Veronika Petláková, spokeswoman for the State Institute for Drug Control (SÚKL), which regulates the Czech Republic’s pharmacological system. The concrete types of formerly prescription drugs released under this regime have yet to be determined, she added.
“The process of moving drugs to the new category will be gradual and pharmacies might begin to sell drugs of this type at the end of next year, at the earliest,” Petláková said.
According to Health Minister Tomáš Julínek, the new category could feature certain types of contraceptives or cholesterol-reducing treatments. The head of the Czech Pharmaceutical Chamber (ČLK), Lubomír Chudoba, added that antibiotic salves and antihistaminic medication should also become more accessible.
“On the other hand, pseudoephedrine medicines — often misused for the production of homemade amphetamines — should be reclassified from over-the-counter to the new category,” Chudoba said.
The increased number of easily accessible medicines will boost the role of the patient in the healthcare system, according to Cikrt. It should also trim public health insurance expenses, as people will have more options to fight minor diseases by themselves, which should curb unnecessary visits to doctors, he added.
Drugs online
Today, there are some 90 Internet pharmacies with SÚKL authorization. According to a 2006 directive issued by the Health Ministry to regulate these businesses, each must only sell over-the-counter drugs registered in the Czech Republic and be operated by a business running a physical pharmacy.
The new bill introduces no novel changes to this directive. However, as the directive has been repeatedly assaulted by some pharmacies as invalid, the law will put the burgeoning e-pharmacy business on a firm legal standing.
The Czech e-pharmacy market is somewhat insignificant when compared with other Internet retail sectors, and the gray legality of the 2006 directive has been one reason for that. A relatively extensive network of domestic pharmacies has also inhibited the growth of e-pharmacies, some experts say.
The state’s condition that Internet pharmacies must operate concrete stores discourages a number of would-be newcomers to the market, companies say. For example, one of the largest Czech Internet retailers, Vltava Stores, has given up on the idea because of this requirement, with its lékárna (pharmacy) online stores selling only vitamins and nutrition supplements, not medicine.
As long as regulations remain as they are, Vltava will not offer prescription-free drugs, said Josef Suchánek, the company’s head.
Despite the market’s relative docility, it could be shaken up next month when the drugstore chain Schlecker — which operates some 150 stores and a handful of pharmacies throughout the Czech Republic — launches its e-pharmacy.
Schlecker’s online store will offer large discounts on drugs and will allow customers to pick up the ordered items in the company’s drugstores. Relatively attractive prices and widely accessible pick-up points might help to bring in a larger share of customers than current Internet pharmacies have achieved.
However, the Schlecker project has raised protests among some pharmacies. They point out that Internet orders should be sent directly into the hands of the buyer or handed out by qualified personnel at a pharmacy. Medicines must not be handled by unqualified personnel in drugstores, they argue.
Schlecker rejects this assertion. The system has already been given the green light by SÚKL, said Schlecker spokeswoman Lucie Řepová.
“The drugs ordered in our e-stores will be packed and handled by qualified staff with pharmaceutical education and sent via our own delivery service directly to the selected drugstore,” she said.

Victor Velek can be reached at vvelek@praguepost.com


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