EU pharmaceutical reform fails to face drug shortage reality – Irish Times

The European Commission will soon publish its proposed reforms of the bloc’s drug regulations. This is the first major revision of medical regulations in 20 years. The draft has been subject to speculation, so much is known about what to expect, saving changes ahead of debate in the European Parliament.

It arrives against the backdrop of a long-term and severe shortage of supplies of vital medicines in Europe that has proven over the past 18 months to be neither seasonal nor resolving over time. .

In Ireland, the media have reported shortages of everything from HRT treatments to shortages of common pain relievers such as the antibiotic amoxicillin and paracetamol, as well as life-saving treatments for leukemia, epilepsy and diabetes. The number and range of medicines, the speed at which they run out, and the duration of shortages should be cause for concern for those who run Irish health policy.

The number of medicines out of stock in Ireland is 248. Twelve months ago it was 167. This means that drug shortages have increased by 48% in just one year. At least 230 medicines have gone missing since the beginning of the year. These statistics are collected through a proprietary index that uses open source data from the Health Products Regulatory Authority (HPRA).

Irish citizens may be wondering why so many common medicines are out of stock in Ireland with such a high density of pharmaceutical companies. The scarce drugs are mostly off-patent, cheap and manufactured offshore in low-cost manufacturing environments.

So far, the Ministry of Health has taken a cold stance on the issues it may directly affect and has taken meaningful action in the wake of unprecedented costs in the low-margin generics industry. was not possible.

Ireland faces challenges as a small consumer market. This is not an issue with newer and more expensive drugs, but where margins are thin due to low volumes. About 40% of the shortages are for single-source off-patent drugs. That is, they are either original brands that are no longer protected by patents, or generic copies of original brands.

One example of a drug that fits this description is alprazolam, better known under its brand name Xanax. It is one of the most commonly used drugs to treat anxiety. Irish prices are €2.22 to treat the condition compared to €2.22 in Ireland based on a pack of 100 0.25mg tablets, compared to €8.71 Less competitive than most of their euro-paying European counterparts. Cost savings that appear to be benefits are actually false positives, with lower prices and volumes making the market less attractive to manufacturers. This could lead to few suppliers of some important medicines.

Ireland spent around €25 million on non-licensed exempt medicines in 2022. This is €7 million more for him than her €18 million of innovative blockbuster drugs allocated across the 2023 budget.

Thirteen of Ireland’s shortages of medicines are on the WHO’s list of essential medicines. For a small peripheral market such as Ireland, this should raise considerable concerns and ultimately lead to excessive overuse of medicines that are not subject to strict regulatory controls and oversight of safety and efficacy standards. These are known as exempt drugs, and their use has masked the seriousness of the shortage situation.

Ireland has spent around €25 million on non-licensed exempt medicines in 2022. This put him €7m more than her €18m of innovative high-priced drugs allocated across the 2023 budget. It is estimated that over 3 million packs of unlicensed medicines were dispensed in Ireland last year. Most of these are used to compensate for the unavailability of licensed products. A supply of exempted medicines is necessary, but must be made on an exceptional basis.

There is a growing consensus in the debate over drug shortages that pricing is the problem. Many European countries have already taken concrete national policy measures. This month, the OECD said low pricing was causing shortages. The Director General of the European Medicines Agency also said price is one factor he said. A report from the European Commission likewise emphasizes that “commercial reasons” are a major factor in drug shortages.

Despite this perception, and surprisingly unfortunately, there are early indications that reforms in the soon-to-be-published report will not address pricing issues at the European Union level. If anything, the proposed reforms would increase control and reporting requirements, increase inventory-keeping obligations, and force manufacturers to continue supplying long after they become commercially viable. and may impose fines for non-supply.

The concern is that regulatory hurdles could drive manufacturers out of the Irish market, turning the problem of persistent drug shortages into a chronic problem.

If decision makers are eager to wait and hope that factors such as inflation, geopolitical events and supply chain disruptions level out, the underlying systemic problems will only get worse. .

Sandra Gannon is CEO of generic drug manufacturer at Azure Pharmaceuticals.

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