Voucher for an antibiotic? National Drug Manufacturers have doubts...

Current EU regulations provide drugs with a monopoly under a 20-year patent and a 5-year supplementary protection certificate, and 8 years of data exclusivity, followed by a 2-year period of market exclusivity, which can be extended for another year (the so-called 8+2+1). The exclusivity periods are the longest in the world in the EU. 

- Reaching a compromise on changing these regulations was not easy, because countries with monopoly drug companies blocked Poland's proposal to speed up competition, explains Grzegorz Rychwalski, vice president of the National Drug Manufacturers. 

Meanwhile, shortening market exclusivity by a year will translate into savings of many millions of zlotys in the budget of the National Health Fund, since - according to our reimbursement law - the first drug entering the market - a competitor of the monopolist - must be cheaper than it by at least 1/4.

An equally important achievement of the compromise reached is the broad Bolar exception, which allows generic manufacturers during the period of a drug monopoly to perform all preparatory activities for the launch of a generic to be available the day after the monopoly expires. 

- Delays in the introduction of competition block many patients' access to therapy, because often only after the price of a drug is reduced after the monopoly expires, the health ministry, having the saved funds at its disposal, changes the eligibility criteria for drug programs allowing more patients to benefit from treatment, Grzegorz Rychwalski points out.

The European organization Medicines for Europe, of which National Drug Manufacturers is a member, presented documented numerous cases of delays and lost savings in member countries. 

Source : Medicines for Europe

The European Commission's idea to increase the production of antibiotics in the EU continues to raise doubts among National Drug Manufacturers. The low prices of these drugs and small sales volumes do not encourage their production. On the other hand, the over-supply of antibiotics could lead to the build-up of microbial resistance to these drugs.

The European Commission proposed that in exchange for marketing such a product, a company would receive a voucher extending the market monopoly it could sell for a year. - In effect, the richest pharmaceutical companies would buy such vouchers from antibiotic manufacturers and extend the monopoly of their most expensive drugs. The Commission would thus pass on the cost of maintaining the production of much-needed antibiotics to patients who, for an additional year of the drug's monopoly in many less wealthy countries, would either be deprived of access to therapy or would pay more for it for that time, Grzegorz Rychwalski explains.

- As part of the negotiated compromise, it was agreed that the voucher applies only to products whose annual gross sales in the EU from the previous four years do not exceed 490 million euros, and the maximum number of vouchers that can be issued was reduced from 10 to five. However, the purchase of a voucher extends the protection of the drug from 11 to 12 years, Krzysztof Kopeć points out.

Also under consideration is the idea of a fixed annual fee for a manufacturer to guarantee access to an antibiotic, regardless of the number of doses used. - Perhaps, as in the case of emergency room funding, we should pay antibiotic manufacturers for their willingness to produce antibiotics and maintain that capacity, Krzysztof Kopeć suggests.