Asia Regulatory Roundup: Leading Drugmakers Pressure Australian Government to Commit Resources to Regulatory Reforms

RoundupsRoundups | 29 January 2019 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
Leading Drugmakers Pressure Australian Government to Commit Resources to Regulatory Reforms
A trade group representing leading drugmakers has called for the Australian government to commit more resources to the implementation of regulatory reforms agreed to in 2017. The reforms cover the development of revised pathways and doubling of access to early advice on new drug submissions.
Medicines Australia, the trade group that requested the updates, and the government entered into a strategic agreement that set out the reform agenda in 2017. The agreement saw the industry sign up to new price policies intended to help the government control healthcare costs in return for certain commitments to streamline the medicines listing process.
Now, around 20 months after signing the agreement, Medicines Australia wants the government to do more to honor its commitments. Writing in a submission to inform the 2019 to 2020 Australian federal budget, the trade group pushed the government to commit more resources to the reforms.
“We recommend that the Australian Government provide greater resourcing to the Department of Health to ensure the timely delivery of the agreed reforms and process improvements. Medicines Australia seeks this resourcing commitment in the upcoming budget, in acknowledgement that the industry is delivering on its funding commitments through legislative changes and consultation on revised cost recovery arrangements,” the trade group wrote.
The request was one of 15 recommendations Medicines Australia put to the government in its budget submission. The trade group also asked the government to “commit to provide regular reports on the progress made against the deliverables” set out in the 2017 agreement.
The deliverables include multiple reforms intended to cut the time and money involved in getting new drugs to market in Australia. Specifically, the government agreed to try to reduce the number of resubmissions to the Pharmaceutical Benefits Advisory Committee (PBAC) by 50%, align processes at PBAC with reformed regulations at the Therapeutic Goods Administration (TGA) and cut the time taken to make drugs available through the Pharmaceutical Benefits Scheme by two months.
While Medicines Australia wants more insights into the progress of these initiatives, PBAC and the government have provided steady updates on some of these activities. For example, PBAC formed a subgroup focused on the creation of revised pathways and provided updates on its progress up to when it submitted a draft proposal to the government around six months ago. After that, PBAC consulted with industry and plans to gather more feedback as it moves toward a July implementation date for the first stage of the process improvements.
These and other updates have kept the industry informed about some of the government’s reforms, but Medicines Australia wants it to implement key performance indicators to improve monitoring of their progress. The 2017 agreement features a clause covering the creation of a joint oversight committee to “manage and monitor” the implementation of the commitments made by the government and Medicines Australia. 
Budget Submission, Press Release
TGA Taking on Staff to Handle Work Created by Reform of Advertising Oversight
TGA is expanding its advertising team to handle the workload created by recent reforms. The extra employees will help TGA handle complaints about the advertising of therapeutic goods and enforce the new code covering the sector.
As of July, TGA has been responsible for handling complaints related to therapeutic goods advertisements. The reform centralized a process that previously involved multiple bodies to make the system simpler and more consistent for advertisers and consumers. In doing so, the changes made work for TGA. Having held its new responsibilities for six months, TGA now knows how much work is involved. 
At its first meeting in October, a summary of which was published this week, the Therapeutic Goods Advertising Consultative Committee noted that TGA received “a very high volume of [advertising] complaints” in its first three months in charge of complaints handling. The level of activity was well above what TGA anticipated based on historical data from the Complaints Resolution Panel.
This week, TGA revealed it received 595 complaints over the second half of 2018. These complaints generated 1,039 cases for action, around 70% of which the agency classed as low-risk.
To process low-risk cases, TGA sends a letter informing the advertiser of the alleged non-compliance and sharing guidance to support compliance going forward. Advertisers do not need to respond to or act on the letters. TGA classes the cases as closed as soon as it sends the letters. As such, the agency had closed 692 of its first 727 low-risk cases as of the end of 2018.
Medium-, high- and critical-risk cases create more work for TGA. The agency will only close these cases when it is satisfied the advertiser has addressed the compliance failing. As of the end of 2018, TGA had closed 47 of the 301 medium-rise cases it initiated over the second half of the year.
With around half of the high- and critical-risk cases opened by TGA outstanding as of the end of 2018, the agency has made the resolution of complaints a priority. TGA is growing its team to support these efforts, stating it plans to take on “more staff with the expertise to conduct reviews of the evidence held by advertisers for their claims.”
TGA has quietly closed most of the cases processed to date, but it has highlighted actions it has taken against some companies. This week, TGA included a notice sent to Evolution Supplements in its feed of news updates. TGA told the firm to stop advertising prescription-only and unapproved medicines. 
TGA Update, Meeting Communique, TGA Warning
India Updates Legislation to Permit Electronic Instructions for Using Medical Devices
India has updated its Medical Device Rules, 2017 to permit electronic instructions for use (IFU). The law now states that “instructions for use or electronic instructions for use” are valid.
The original medical device legislation made no mention of the format of the IFU. That led the Medical Technology Association of India (MTaI) to make “several representations” to the Central Drugs Standard Control Organization to try to get electronic IFUs accepted in India, according to the trade group.
Government officials signaled an interest in clarifying the situation in September with the publication of draft changes to the law. The draft added “or electronic instructions for use” to every mention of IFU. Having closed the comment period on the draft, the government has now gone ahead with the changes.
The Indian medical device industry welcomed the change. In a statement, Pavan Choudary, chairman of MTaI, said electronic IFUs “will improve users access to more detailed and up-to-date information” and bring practices in India in line with advanced regions such as Europe and the United States. Choudary thinks the change is particularly important for some types of devices.
“Many products cannot be supplied with paper IFU as the product is transferred to the loaner kit in the supply chain and sterilized before being supplied to the doctor,” Choudary said. “The acceptance of eIFU will remove such issues.”
Legislative Notification, MTaI Statement
Other News:
TGA has declared the shortage of EpiPen 300 mcg adrenaline auto-injectors in Australia to be over. Australia, like countries around the world, suffered shortages throughout parts of last year as a result of manufacturing delays. Following an increase in supplies over the second half of 2018, TGA thinks there are now enough auto-injectors to meet current patient needs in Australia. TGA Statement 


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