In an effort to combat drug shortages, the Czech health ministry is pushing forward an amendment that significantly changes the role of all players in the pharmaceutical market – though concerns have been raised about additional costs without adequate compensation.

While the new EU Pharmaceutical Legislation – which seeks a more coordinated approach among member states to pre-empt medicine shortages – is being discussed in Brussels, Prague is seeking its own short-term solutions to an issue that has caused severe headaches to the government.

“This amendment represents one of the biggest reforms of the pharmaceutical legislation in the last 15 years, significantly increasing the resilience of the Czech pharmaceutical market against shortages and fundamentally strengthening the position of patients,” Health Minister Vlastimil Válek explained.

‘Obligations’ for manufacturers, distributors

The current wording of the Czech law requires manufacturers to report any interruption of medicine supply on the market two months in advance.

According to the proposed amendment, such a shortage will result in a new obligation: After a supply interruption has been signalled to relevant authorities, the manufacturer must supply the market with a quantity equivalent to twice the average monthly supply.

If the manufacturer has marketed the medicinal product concerned without interruption of supply in the last two years, it is sufficient to ensure one average monthly supply.

However, the amendment does not specify any further parameters in relation to these mandatory supplies – for example, there is no provision requiring manufacturers to keep stocks in the country. The only obligation is to supply the medicine, even from abroad.

Authorities will also be able to place a specific medicine on the “restricted list” by an emergency measure. In this case, export restrictions will be imposed on the distributors.

Initially, they will be obliged to inform Czech authorities of how many packs of such a product are in stock, and will not be able to export these medicines abroad. If a pharmacy orders medicines from a restricted list, distributors will have to deliver them within two working days.

Pharmacies will be obliged to order such marked medicines in limited quantities corresponding to an average stock of one to two weeks.

The aim is to prevent some pharmacies from building up excess stocks and thus limiting the availability of the medicine in other pharmacies.

Pharmacists still unconvinced

The amendment is now being discussed in the Czech Parliament. While the ministry is convinced that the amendment will help to solve the shortages, some pharmacists are sceptical.

“A number of things are not resolved in the amendment at all. Some rights and responsibilities between manufacturers, distributors and pharmacies are not linked,” Marek Hampel, chairman of the Czech Pharmacy Owners’ Association, told Czech Radio.

For example, the amendment does not cover over-the-counter drugs but only prescription medicines.

In Hampel’s opinion, the amendment also wrongly abolishes the protected distribution channel – an existing obligation aiming to ensure that medicines are universally available to patients.

However, the health ministry insists that the amendment is introducing a different business structure that will be more in line with competition.

Fear of penicillin shortage grows

The debate over the law amendment is closely followed by the Czech public as local pharmacies have experienced several shortages of specific drugs this year. Currently, the problem concerns antibiotics, especially penicillin.

Over recent weeks, doctors and pharmacists have warned that since penicillin is not available in some pharmacies, they are prescribing broad-spectrum antibiotics unnecessarily.

The Czech Health Ministry said that more than 20,000 packs are available in the country, which should cover the monthly consumption of this drug – however, the ministry has no data on which pharmacies stock penicillin and which face shortages.

As the autumn and winter seasons approach, concerns about penicillin shortages are rising. The ministry has, therefore, been in contact with manufacturers, who have promised to supply enough packs to cover consumption with a total of 300,000 packs of penicillin antibiotics and syrups.

“We have managed to negotiate with the manufacturers and distributors that the consumption will be fully covered during the next season. This is more than sufficient reserve even in case of higher consumption,” Minister Válek said.

Industry: No compensation for additional costs

Pharmaceutical companies confirm that they will increase antibiotic supplies to the Czech market. However, they do not believe the planned law amendment will prevent similar problems in the future.

“We believe that the benefits of the amendment for increasing the availability of medicines will be minimal, and at the same time it will bring everyone enormous costs and a lot of extra administration,” said Filip Vrubel, director of the Czech Association of Pharmaceutical Companies representing manufacturers and suppliers of generic medicines.

“However, the state does not plan to compensate pharmaceutical companies for these costs,” he continued.

The association argues that the state encourages all pharmaceutical companies to increase the supply of antibiotics but does not guarantee their purchase.

According to generic manufacturers, the state should build strategic reserves of medicines, either in the form of purchasing these medicines or by reserving production on the basis of framework contracts between the state and pharmaceutical companies. However, such solutions are not yet on the table in the Czech Republic.

Further measures

In addition to negotiations with manufacturers and an amendment to the law, the Czech ministry said it is working on further measures.

Strengthening medicine production in the country and across the EU is among them. The ministry is currently preparing a sector analysis of the pharmaceutical market in the Czech Republic to identify potential gaps.

Another solution is strengthening competition in the Czech pharmaceutical market by bringing in manufacturers from other countries. According to Válek, the ministry is already in negotiations with them.

The Czech minister also emphasised that the issue is being addressed at the EU level, with plans to hold joint stocks and purchases of essential medicines.

(Aneta Zachová, Euractiv.cz – Edited by Vasiliki Angouridi, Sarantis Michalopoulos, Nathalie Weatherald | Euractiv.com)

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