Hungary wants new approach to manage growing drug shortages [Advocacy Lab Content]

Hungary’s Minister of State for Health, Péter Takács, has said a new approach is needed to allow Hungary to choose medicines better suited to the national health budget.

Drug shortages are a growing problem for patients across the EU, but Hungary has reported one of the highest instances of total and critical shortages within Europe. To help address the issue, 313 active substances have been defined – pharmaceutical wholesale companies must accumulate stocks of each.

At the end of last year, 1,567 missing preparations were listed in the database of the Hungarian National Pharmaceutical Authority (NNGYK). Of the active ingredients on the list, pharmaceutical wholesale companies must keep stock levels corresponding to 1/12 of the amount sold during the previous 12 months.

Addressing medicines shortages, the State Secretary underlined, “Although the pharmaceutical package contains good suggestions, there cannot be a safe supply of medicines without strong European manufacturing capacities, and especially active ingredient manufacturing capacities. We therefore expect further actions taken by the Commission.”

“Hungary can also play an active role in strengthening active ingredient production in Europe,” he added. With Hungary’s EU Presidency approaching, Budapest will be represented at the Critical Medicines Alliance meeting next week in Brussels (24-25 April).

Constant shortages

Hungarian pharmacies face short supplies of insulins, Rivotril, some antibiotic products, pacemakers, and Neo Citran among others. In 2023, much-used anti-anxiety medications were not available in pharmacies, which also have occasionally been facing shortages of certain ophthalmic medicines.

Last winter, desperate parents sometimes had to travel hundreds of kilometres to get the medicines they needed to treat their children.

In the coming weeks, medicines for upper respiratory tract infections and a few antibiotics will not always be in stock in pharmacies.

Under the new decree, the NNGYK will publish a notice on its website about the medicinal products that contain the active ingredient and are on the Hungarian market.

The listed medicines produced in Hungary will be marked with the symbol “SH”, and medicines of manufacturers with production sites in Hungary with the symbol “S”.

The list in the notice will be reviewed every six months and amended if necessary.

The decree enters into force approximately in mid-May.

A multifaceted problem

In European countries, anti-infectives and medicines for the nervous system were found to account for a higher proportion of critical shortages.

The shortage can be due to various reasons, such as a lack of raw materials, production, transport and storage problems, administrative problems, market considerations, and increased demand.

Productivity could be alleviated by increasing production capacities, but due to high energy prices, several manufacturers do not dare to do so, especially since the production of subsidised products has been increasingly unprofitable for them for years.

Member States cooperation

The European Medicines Agency (EMA) and the Union itself are aware of the problems. Global trends have also increased the need for cooperation between EU member states. International cooperation has been developed to help anticipate imminent shortages of medicines and to take joint action on both procurement and information to tackle shortages.

The Critical Medicines Alliance, announced on October 2023, is a major change in pharmaceutical manufacturing and supply chains that will allow authorities, industry players, civil societies, the Commission, and EU agencies to initiate and proceed with coordinated actions against shortages of critical medicines by setting goals and driving changes.

The drafting of the Union list is done in phases, and the publication of the first version marks the end of the first phase. During 2024, the review will continue and extend to other authorised medicines in the EU not yet included in the version.

The first recommendations are expected in autumn 2024.

High demand and supply issues

According to Dr Antal Feller, President of the Association of Pharmaceutical Wholesalers, “It is not because wholesalers do not order the given product.”

During the latest meeting of the Chamber of Pharmacy regarding shortages, he emphasised the responsibility of manufacturers, highlighting the need to address all actors in the sector, such as the authority, manufacturers, pharmaceutical wholesalers, pharmacists, clinical pharmacists, and physicians.

For Dr Géza Muzsay, vice-president of the Association of Paediatrician General Practitioners: “Enhanced demands or unpredictable production/supply problems are primarily responsible for the shortages; immediate replacement is not easy.”

He explained, “There are serious cases when certain medicine licenses are deleted for various reasons, quite often at the manufacturer’s request.”

“In this case, information about the substitute product should be obtained from the attending physician, who knows the patient’s medical history well. If a medicine becomes in short supply, there is usually a substitute product,” he added.

[By Zsolt Kopári, Edited by Vasiliki Angouridi, Brian Maguire |Euractiv’s Advocacy Lab]

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