13 April 2020
Pharmaceutical collaboration on the management of essential medicine supplies for Australian patients
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 recognises the critical role we must play now in this rapidly evolving health crisis. 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.
The supply of medicines is our utmost priority – importantly identifying and producing treatments and preventive medicines to fight COVID-19 and ensuring the supply of all essential prescription medicines to Australians who rely on them.
To succeed, every aspect of the Australian healthcare delivery system has an essential role to play and it is imperative we work together now in a collaborative and supportive way.
Medicines Australia (MA) and the Generic and Biosimilar Medicines Association (GBMA) were granted interim authorisation from the ACCC on 3 April 2020 to allow medicine suppliers to collaborate more closely on managing supply and stocks for Australia. The authorisation applies to members of Medicines Australia and the GBMA, and other relevant medicine suppliers who are notified to the ACCC.
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 National Pharmaceutical Services Association (NPSA) separately has also received an interim authorisation to manage stocks at the local level. The NPSA may join with the Medicines Australia/GBMA authorisation if necessary.
Medicines Australia and the GBMA 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.
Interactions with Government
Both organisations are working in close partnership with Government providing continuous status updates to the Therapeutic Goods Administration (TGA), over and above the standard monitoring procedures, on all medicine supplies and importantly those on the high priority list. Potential areas of need will be identified early to facilitate appropriate mitigating strategies.
Since 10 March 2020 the key representatives of the medicines supply chain in Australia have been part of the COVID-19 Medicines Shortages Sub-group. It 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. The sub-group is focused on the manufacturing, import and wholesale distribution portion of the pharmaceutical supply chain.
Both Medicines Australia and the GBMA are part of parallel working industry roundtables with the TGA and the Minister for Industry, both of which are meeting weekly, to help manage these challenges. We are also interacting with other relevant government departments to ensure a continuous flow of two-way information.
Medicines Australia and the GBMA remain highly vigilant with all aspects of the local and global supply chain – actively tracking, monitoring and managing the situation both within Australia and at a global level. On a global level companies are carefully tracking and managing not only the delivery of their medicines to Australia but also, for those that manufacture, they are tracking and managing all the inputs required to continue manufacturing.
All countries around the world, involved in the production and manufacture of medicines are being monitored extremely closely – this includes India and China, Europe and the United States. Medicines Australia and the GBMA are working closely with Government to actively monitor the major sources or the manufacture and export of Active Pharmaceutical Ingredients (API).
At the same time China is now ramping up its manufacturing of APIs and is equally being monitored as it reactivates the global manufacturing chain. Logistics and border closures are also actively being worked on with Government.
At an international level, the International Generic and Biosimilar Medicines Association (IGBA) www.igbamedicines.org and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), amongst others, are working with many other jurisdictions to ensure medicines can come through restricted borders via pharmaceutical ‘green lanes’.
There are ongoing challenges with availability of air freight following the significant reduction in air transport services and Member companies are dedicating all efforts to prioritising the flow of medicines into Australia. 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.
Dynamics of Global Supply
Medicines imported into Australia are made in numerous countries all over the world, generally with more than one country involved in the manufacture of a specific medicine.
Companies bringing medicines into Australia have planned their requirements for the local market many months in advance. The production and lead times vary greatly between complex specialised medicines compared with high volume [non-patented] over-the-counter or prescription medicines.
The technology and manufacturing processes between different types of medicines also vary greatly. Just like a number of complex technologies, countries globally may specialise in specific types of medicines or parts of the medicine production process. Some countries are also important for active ingredients for some complex medicines or produce a number of high volume medicines (like China and India).
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.
Local Supply Chain
In addition to the measures previously outlined, Medicines Australia and GBMA members are also working with the wholesalers to manage the surges in demand that have occurred locally for certain medicines. These can be managed 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. We understand these measures appear to be having an overall impact.
The granting of the interim authorisation from the ACCC, which will allow Medicines Australia and GBMA members, together with other non-member medicines suppliers, to work closely on managing supply and stocks for Australia, is welcomed by both associations.
Medicines Australia and the GBMA advises Australians who are concerned about the availability of their medicines to check the TGA website and to discuss their concerns with their doctor or pharmacist or the company directly, through their customer service lines.
Medicines Australia (MA) members represent pharmaceutical companies who discover, invent and create originator products and are actively involved in the original research and development, clinical trials, and the manufacturing and supply of new, innovative medicines on the PBS.
Natalie Wimmer 0450 728 660 firstname.lastname@example.org
Generic and Biosimilar Medicines Association (GBMA) members represent pharmaceutical companies who manufacture, supply and market generic and biosimilar medicines, which account for the largest volume percentage of medicines on the PBS.
Jannette Cotterell Executive Counsel Australia. 0419 204 059 email@example.com
The GBMA is the national association representing companies that manufacture, supply and export generic and biosimilar medicines. GBMA represents all major generic medicine suppliers in Australia, accounting for more than 90% of all generic medicines dispensed in Australia. Members of GBMA ensure all Australians are offered high quality generic and biosimilar medicines, which provide affordable health outcomes that benefit all Australians. Members of GBMA take seriously their role in the responsible provision of affordable medicines in Australia, as stipulated in the National Medicines Policy. The generic and biosimilar medicines sector is a high value-add sector delivering significant health and economic benefits to the Australian public. The availability of generic medicines in this country helps to deliver:
– Timely access to affordable medicines;
– Substantial savings to the PBS;
– Thousands of highly skilled jobs; and
– Domestic manufacturing and annual exports of around $300 million.