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Australia’s Generic and Biosimilar Medicines Association and brand industry body Medicines Australia have set out a joint position statement explaining how they intend to work together to facilitate the supply of medicines amid the coronavirus pandemic.
The move comes after the Australian Competition and Consumer Commission recently granted a “conditional interim authorization” to allow the generic and brand industry associations to share information on stock levels, inventory, manufacturing and the supply chain, but not on tender pricing. (Also see "Australia Relaxes Competition Rules To Facilitate Coronavirus Response" - Generics Bulletin, 6 Apr, 2020.) Although it has been allowed to enter into force immediately, the authorization remains subject to a consultation which is ongoing until 27 April.
“This important step is in the national interest and places pharmaceutical companies in the best possible position to manage the unprecedented COVID-19 situation and supply of prescription medicines,” the GBMA and Medicines Australia insisted.
They also noted that Australia’s National Pharmaceutical Services Association had received an interim authorization separately that will allow it to manage stocks at the local level. “The NPSA may join with the Medicines Australia/GBMA authorization if necessary,” the organizations stated.
According to the GBMA and Medicines Australia, both associations are “working extremely closely with their members to monitor, pre-empt and address any medicine supply issues resulting from COVID-19.” This includes “continuous monitoring and assessment of stock and supply of specific medicines locally and globally, together with the management of priority and urgent needs relating to transportation and freight.”
Continuous status updates being provided by the associations to Australia’s Therapeutic Goods Administration were going “over and above the standard monitoring procedures,” they pointed out, covering “all medicine supplies and importantly those on the high priority list.”
Mitigation strategies would require potential areas of need to be identified early, they suggested, with key supply-chain representatives in Australia having already participated in the COVID-19 medicines shortages sub-group since 10 March. This group “brings together a targeted group of stakeholders, including Medicines Australia, the GBMA, and the NPSA, to work closely with the federal department of health, particularly the TGA and the medicine shortages division” and is “focused on the manufacturing, import and wholesale distribution portion of the pharmaceutical supply chain. “
Both Medicines Australia and the GBMA are also participating in parallel industry roundtables with the TGA and Australia’s ministry for industry, “both of which are meeting weekly to help manage these challenges.” The “continuous flow of two-way information” also involved other relevant government departments, they noted.
While the tracking and monitoring of the situation being carried out by the GBMA and Medicines Australia is partly within Australia, they underlined that it was also important for them and their members to track global developments. This extended to “not only the delivery of medicines to Australia but also, for those that manufacture, tracking and managing all the inputs required to continue manufacturing.”
This meant it was necessary to monitor all countries and regions involved in producing and manufacturing medicines, they said, particularly India, China, Europe and the US.
“Medicines Australia and the GBMA are working closely with government to actively monitor the major sources of the manufacture and export of active pharmaceutical ingredients,” they insisted, observing that “China is now ramping up its manufacturing of APIs and is being monitored as it reactivates the global manufacturing chain.”
“Given the challenges that are arising with importation issues, Australia’s role in the worldwide manufacturing supply chain will be reviewed post the pandemic, to determine whether it can strengthen its position.”
“Companies bringing medicines into Australia have planned their requirements for the local market many months in advance,” the associations explained, with production and lead times varying significantly between complex specialized medicines and high-volume off-patent over-the-counter or prescription medicines.
“The technology and manufacturing processes between different types of medicines also vary greatly,” they acknowledged, with different countries specializing in specific medicines or parts of the production process.
“Given the challenges that are arising with importation issues,” they commented, “Australia’s role in the worldwide manufacturing supply chain will be reviewed post the pandemic, to determine whether it can strengthen its position.”
Logistics and border-closure issues were also actively being worked on with Australia’s government, the association said, pointing to action taken on a global level by the International Generic and Biosimilar Medicines Association to seek open freight routes or “green lanes” to allow medicines to pass through restricted borders. (Also see "Medicines Must Be Designated As Priority Items, Says IGBA" - Generics Bulletin, 6 Apr, 2020.)
“There are ongoing challenges with availability of air freight following the significant reduction in air transport services,” the GBMA and Medicines Australia acknowledged, “and member companies are dedicating all efforts to prioritizing the flow of medicines into Australia.” (Also see "Reduction In Flights Hits Global Supply Chain" - Generics Bulletin, 23 Mar, 2020.)
“Additionally, the Federal government is liaising with companies and airlines to provide as many freight options as possible to meet our hospital and community needs.”
Meanwhile, within Australia wholesalers were working with the associations to manage surges in demand occurring locally for certain drugs. “These can be managed,” the GBMA and Medicines Australia insisted, “and we are urging the community and others not to stockpile medicines and to obtain only the quantities they require to meet their immediate needs.”
“We fully support the current government measures to reassure patients and the community on availability of medicines and manage the level of dispensing on selected medicines,” they added, observing that “these measures appear to be having an overall impact.”
Welcoming the ACCC’s authorization to allow them to work more closely together, the associations emphasized that “we are facing one of the biggest global health challenges of our time.”
“As the creators, manufacturers and suppliers of medicines, the pharmaceutical industry in Australia recognizes the critical role we must play now in this rapidly evolving health crisis,” they said. This meant “not only contributing to the urgent and immediate response to COVID-19, but also maintaining the health of all Australians and supporting our nation’s overall recovery in terms of our health and economy.”
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