EMA supply interuption rules need clarification says industry; NGO says high prices cause shortages

By Gareth Macdonald contact

- Last updated on GMT

Genzyme's Fabrazyme costs $160,000 a year and is listed in the EMA shortage catalogue; Global supplies were hit by manufacturing problems in 2010
Genzyme's Fabrazyme costs $160,000 a year and is listed in the EMA shortage catalogue; Global supplies were hit by manufacturing problems in 2010

Related tags: Pharmacology

Rules governing when drugmakers should warn regulators about supply interruptions need to take mitigation plans into account according to European industry groups.

This week European drug industry groups EFPIA, AESGP, EGA and PPT published principles designed to let members know when, how and what information they should provide to regulators if they identify a manufacturing problem likely to result in shortages.

According to a joint statement the idea is to establish “a harmonised approach to the communication of information by MAHs, meeting the complex and divergent data requirements across national CAs and EMA.”

Trigger point

Under current legislation, marketing authorisation holders (MAHs) are required to let authorities know within 20 days of detecting a quality or manufacturing issue that could interrupt production.

This so called 'trigger point' needs clarification according to the industry groups, which argue that the deadline does not take into account that most drugmakers launch efforts to prevent disruptions as soon as they detect a problem.

On initial assessment the alternate plan may appear to be adequate to avoid a likely supply disruption, but as the plan progresses and other events occur, a supply disruption may become “likely”.

It is important to clarify that the trigger to notification would be at the time the applicant becomes aware or reasonably should have become aware that a meaningful disruption is likely to occur, which in some cases will be after an initial potential disruption is identified​.”

Public information

Another area covered in the principles document is public notification. The industry groups suggest announcing potential quality-related drug shortages should be considered on a case by case basis to avoid unintended consequences.

Any information in the public domain related to a potential shortage could create further disruption of the supply of drug products at different levels in the distribution chain by inadvertently encouraging hoarding, for example.

Therefore, the public release of information related to potential supply disruption due to manufacturing and quality issues should be carefully assessed to avoid creating this problem… Thus, notifications between the MAH and CAs should be kept confidential until public communication is required and agreed upon by both parties.”

EMA call for industry action

The industry groups say the principles are a response to EMA calls for “voluntary and proactive action​” to prevent drug shortages in Europe.

Supply interruptions have been a focus for the EMA since 2011​ when quality problems at a plant operated by now closed contract manufacturing organisation (CMO) Ben Venue caused shortages of various injectable cancer drugs.

In 2012​ the agency issued a draft shortages management​ plan, the finished version of which was adopted last year​.

While the principles were welcomed, some observers suggested preventing shortages called for a more holistic approach.  

Health Action International (HAI) director, Tim Reed, told us “while it’s commendable that the industry is committed to keeping drugs flowing in the supply chain to ensure continual access, it’s a shame it doesn’t do more to improve access to high-cost medicines​.”

He cited drugs used to treat hepatitis C and cancer and said: “There is a constant threat of shortages for these medicines because governments and patients simply can’t afford the prices​.”

Related topics: Markets & Regulations, QA/QC, Regulations

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