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Medicine legislation changes

THE PHARMACEUTICAL industry was again the focus of legislators on October 16, when the Slovak Parliament advanced several pharmaceutical-related bills to their second readings. Before becoming effective they need a final nod from parliament and presidential approval.

THE PHARMACEUTICAL industry was again the focus of legislators on October 16, when the Slovak Parliament advanced several pharmaceutical-related bills to their second readings. Before becoming effective they need a final nod from parliament and presidential approval.

The draft revision to the law on medicine, elaborated by the Health Ministry, reintroduces a ban on loyalty schemes in pharmacies.

“Competition between public pharmacies for patients should be led at a professional level,” the ministry stated as cited by the SITA newswire. It proposes to prohibit the provision of cash or non-cash benefits and donations for medicines, dietary foods and medical devices which are available only by prescription. By cancelling such benefits, the ministry wants to remove practices that lead to increased consumption of drugs, including those that are not prescription-only. The draft revision also introduces changes for providers of pharmacy care. It effectively abolishes networks of pharmacies by suggesting that a private individual or a company can only establish one public pharmacy and one branch of that pharmacy. Among other changes is a measure to prevent the entry of counterfeit drugs into the legal supply chain. The Health Ministry also proposes that the export of drugs should be subject to monitoring by the State Institute for Drug Control. If a specific medicine is scarce in Slovakia, the institute will not allow its export. If parliament adopts the draft, the revision will become effective on January 2, 2013.

MPs also advanced to its second reading a draft revision to the law on the scope and conditions for payments for medicines, medical aids and dietetic foods, also elaborated by the Health Ministry, thereby changing the current price-setting mechanism for medication. Currently, the maximum price of medicine in Slovakia cannot exceed the second lowest price in the European Union. Based on the new mechanism, the price should not be higher than the average of the three lowest prices in the EU, the TASR newswire reported.

The aim of the revision is to introduce a fairer price-setting method, taking into consideration changes in prices in other EU member countries and exchange rates. The revision also tightens conditions for the entry of generic drugs onto the market. Based on this the price of generic drugs should be set at 35 percent below the price of the original brands (currently it is 30 percent).

The revision also changes the way in which vaccines are purchased for compulsory vaccination. Physicians currently finance the purchasing of these vaccines from their own resources. The revision will return to the previous system, whereby a pharmacy provides vaccines to physicians or patients based on a receipt, to be reimbursed later by the health insurer. The ministry argues that under the current system vaccinations were postponed, often for financial reasons.

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