Market access is the process that companies must undergo to ensure that their products are available in a market (typically a country) while also ensuring they are adequately reimbursed for developing that product. Market access is a two-stage process. The first is securing regulatory approval. But for many drugs, especially ones developed at high cost, securing a listing on the Pharmaceutical Benefits Scheme (PBS) is just as important to actually motivate patients to purchase it.
Failure to secure timely approval for a drug can bring down an entire company.
Broadly speaking, regulatory approval to sell a drug in a market seeks to answer the most fundamental questions: does the product work as intended?
Making it affordable via subsidy is more about the economics: how large is the addressable market for the product?
What is its likely health impact
Is it cost effective?
Market access is also bilateral: Australian companies are interested in accessing new markets but also mindful of competitors accessing the Australian market.
A significant challenge for regulators – and therefore for companies seeking to access new markets – is that pharmaceutical technology is progressing more quickly than regulation. As drug development becomes more costly and technologically intensive, regulators are coming under greater pressure to both understand how a therapy works and approve its use in a timely manner. This also means that innovative new therapies do not always fit into existing regulatory categories – making the reimbursement challenge that much more complex.
There are substantial other pressures on Australian pharmaceutical companies. Some, like the tangling of global supply chains due to the Covid-19 pandemic, are new. Others, such as pricing strategies and reimbursement, are not. Drastic price reductions for a drug might not always be good news for a company: greater use may be offset by much lower prices. ‘Comparator erosion’, which is when a new therapy is priced against a generic or relatively old therapy with a low price, has also been cited as a concern.
Government plays a hugely important role in market access on both ends. In Australia, the Therapeutic Goods Administration (TGA) is responsible for the market authorisation of new therapies, a process which ensures that the products in question are safe, perform as intended and meet the appropriate standards for use in Australia. Equivalent regulatory agencies perform the same roles in other countries.
Generally speaking, regulators face a trade-off between speed and thoroughness. It is not always easy to know where the optimal trade-off lies: consumers like to know that novel products are safe, but might not like that it takes years for them to make it to market. In comments provided exclusively to HPG, Medicines Australia CEO Elizabeth de Somer thinks that we haven’t got the balance quite right in Australia. This is why Medicines Australia recommends that the Australian Government develop a plan to shorten the time that patients wait for access to the latest medicines, vaccines and treatments. De Somer says that Australians currently wait significantly longer than consumers in other countries. Globally, more than 60 per cent of medicines become available within six months of completion, compared to 22 per cent in Australia.
However, it should be noted that the Australian Government has not been silent on market and consumer access issues. In September 2021, it announced ‘landmark’ new medicines agreements to improve consumer access.
Whether for start-ups looking to grow quickly or established companies looking to protect their position, market access skills are always in demand. A quick listing on the PBS (or its equivalent in other markets) can be the difference between a new product’s success or failure.
Market access and, more broadly, regulatory affairs roles can often be performed by people without strong technical or scientific backgrounds. Having such skills will certainly help, but helping your company access new markets is often more about knowing how to form and sustain productive relationships with senior regulators and government decision-makers. If you are a people person who is good at influencing outcomes in a positive manner, then we highly recommend getting in touch with an HPG consultant to learn if you would be a good fit for such a role.