Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
‘Major Failings’ of Drug Shortage Protocol Prompt Australia to Propose Mandatory Reporting
Australia is considering making the reporting of all medicine shortages mandatory from the start of next year. Government officials floated the idea as a way to improve the current system, which the Therapeutic Goods Administration (TGA) said has “major failings” in a consultation about its planned changes.
TGA last sought to improve the management of supply constraints with the 2014 adoption of the Medicine Shortages Information Initiative (MSII) and associated protocol. The MSII protocol asks sponsors to alert TGA “as soon as a medicine shortage is anticipated or known.” However, as participation in MSII is voluntary, the program has faIled to live up to expectations.
“A significant number of shortages of extreme or high patient impact have not been reported by some sponsors. Instead, the first indication that the TGA received of these medicine shortages has in many cases been from correspondence from members of the community impacted by a shortage,” TGA wrote in its consultation. TGA tries to confirm drug shortages with the relevant sponsors after learning of them via other sources, but this can cause “significant delays.”
The upshot is TGA is unable to support the search for alternative supplies of drugs from overseas or encourage the judicious use of remaining stocks of a medicine. TGA has spent the past eight months talking to the industry and government about how to better manage drug and vaccine shortages.
That led to the new protocol that is now open for feedback. TGA wants sponsors to contact it when they learn of potential shortages “to facilitate early investigation with proactive forecasting and management.” If a shortage occurs unexpectedly, sponsors must contact TGA so it can conduct an urgent investigation. In cases when TGA contacts a sponsor about a shortage, the agency wants to receive a response within two business days. TGA is considering penalties for noncompliance.
TGA will treat reports as confidential, but will publish details of supply constraints if they are deemed to have a “high” or “extreme” effect on patients. Information about such shortages will feature on the homepage of a revised MSII website. Sponsors of supply-constrained products with less impact on patients can refuse to allow TGA to publish details of the shortage. However, TGA will “strongly encourage” sponsors to allow the release of details of all shortages.
The agency is now gathering feedback on its proposals. TGA wants to know whether people agree with its definition of a medicine shortage and the range of products to which the rules will apply. The agency is also seeking feedback on the proposed reporting timelines and a list of drugs that would automatically trigger a “high” or “extreme” risk warning when in short supply.
, Draft Protocol
Politicians Pressure TGA to Overhaul Post-Market Monitoring Following Mesh Adverse Events
Politicians have called for TGA and the Australian government to overhaul the reporting and handling of adverse events. The Senate committee made the recommendations after learning of a history of underreporting of adverse events linked to transvaginal mesh implants and finding fault with the speed of TGA’s response.
The committee’s report makes 13 recommendations, many of which would affect TGA if adopted. The report calls for the government to make it mandatory for medical practitioners to report adverse events, improve awareness of the reporting system and make it easier for people to submit reports. Other recommendations include the creation of a registry of high-risk implantable devices and the strengthening of the post-market monitoring scheme.
Those and other recommendations made in the report are designed to address the issues the Senate committee learned of when reviewing the history of use of transvaginal mesh implants in Australia.
The review revealed that TGA only received 12 reports of adverse events related to the implants by the end of 2015. The dearth of reports made it hard for TGA to assess the risk-benefit profile of the implants and, in the Senate committee’s view, “provided a false indication of the safety of such devices and contributed to delays in responding to the issues identified.”
The committee identified multiple possible causes of the underreporting. Many patients did not know they could report adverse events. As knowledge of TGA and adverse event reporting spread via online forums, the rate of reporting was potentially curbed by the difficulties patients faced when trying to access information requested by TGA. Some people found the process “daunting.” Others expressed surprise and frustration that their surgeon had not already filed a report.
Making medical practitioners report adverse events, as advocated by the report, would go some way to preventing underreporting. However, campaigners are concerned the recommendations may fail to translate into meaningful changes.
“The wording used in the recommendations are so weak that it could, if not followed up by robust policy change, give Australian health authorities, specialists and primary carers permission to carry on as usual,” a consortium of pelvic mesh support groups wrote in a statement.
The committee has tasked the government with providing reports on the progress of some of its recommendations by late November.
, Press Release
New Zealand Proposes First Fee Hike Since 2006 as Surplus Runs Out
New Zealand is planning to increase its regulatory service fees for the first time since 2006. The Medicines and Medical Devices Safety Authority (Medsafe) wants to charge companies 15% more to process marketing and clinical trial applications.
Medsafe cut its fees by an average of 12% in 2009 after discovering a surplus and has kept them at that level ever since. Having depleted the surplus, Medsafe is set to increase the fees to account for a rise in its costs over the past decade. Medsafe plans to tie the increase to changes in the consumer price index since it last reviewed them in 2008.
The price index has risen 14.4% over that period, leading Medsafe to propose a 15% increase to the fees it charges to approve or modify medicines and sign off on clinical trials. The fee for intermediate-risk new medicine applications will remain the same.
Medsafe is accepting feedback on the proposals until 27 April. The agency plans to introduce the new fee schedule on 1 June.
TGA Starts Consultation on Revised Therapeutic Goods Advertising Code
TGA is seeking feedback on planned changes to the therapeutic goods advertising code. The agency drafted the code in light of a consultation it carried out last year and the findings of the expert review of Australian drug and device regulations.
The draft features around 10 new provisions, although some of these changes are similar to sections of the existing code. Wholly new additions include a requirement for advertisements to clearly state if a drug is linked to serious allergic reactions and a ban on promotions that are inconsistent with active public health campaigns. TGA also wants to change the list of defined terms included in the code.
TGA received pushback during its initial consultation from trade group Medicines Australia, which raised concerns about plans to prohibit the identification of the sponsors behind disease awareness campaigns. The draft code released this week makes no mention of disease awareness campaigns.
TGA is accepting feedback on the draft until 27 April.