Regulatory headaches stifling access to medicines: PwC report

red tape

TGA regulation, price pressure and compliance issues are reducing access to medicines, and reducing industry confidence, a PwC report claims.

Challenges and Change—a report on the Australian pharmaceutical industry, released today, canvassed the views of representatives from 23 organisations including industry bodies and pharmaceutical companies. More than 50% of companies surveyed had annual turnovers in Australia of more than $100m.

The TGA was cited as a key source of frustration, with 65% of respondents saying processes around registration have not improved, or worsened, in the last two years.

Respondents also expressed grave concerns about regulatory and market access; saying they are experiencing an increased regulatory burden across a range of areas.

PwC Australia’s health leader, John Cannings, says there is universal agreement in the industry on the benefits of having an independent, Australian regulatory agency for approvals.

But he concedes that an absence of collaboration with overseas regulators, and scarcity of resources is slowing approvals; and preventing patients from accessing medicines that available in other jurisdictions.

“What the industry is looking for is more efficient processes and greater collaboration with international regulators,” says Cannings.

“For example, the current process include a requirement for Australian-specific clinical data, even in instances where the drug has already been sanctioned in the US and Europe.

“A ‘fast-track’ approval mechanism for drugs with high clinical need, and lifesaving therapies, would be welcomed by Australian industry and patients.”

Another area of concern is the costs and processes required to get medicines listed on the PBS.
Almost three quarters of respondents say the PBAC imposes a significant regulatory burden in 2014: an increase of 55% on 2012. The corollary is that companies are more reluctant to present drugs for PBS listing.

In the past two years almost 90% say they considered not applying for PBAC reimbursement because of concerns that the PBS price would be uneconomic. This compares to the reported 52% of products being withdrawn or not applied for in 2012.

According to Cannings, there are some benefits of having a rigorous assessment before a product is brought to market.

“Pharmaceutical companies should understand that the Government needs to balance the cost to taxpayers against the clinical benefit of a new drug,” he says.

“In that context, it makes good business sense to only be applying to register drugs that will deliver the greatest benefit to patients, and the greatest value to the taxpayer.”

However, Medicines Australia CEO Tim James says the local medicines industry is facing “significant challenges.”

“The PwC survey shows that our member companies are facing an increasingly difficult reimbursement process, along with the Federal Budget measures, leading to delayed access to some new medicines,” he says.

Despite these challenges, the report claims industry is still broadly optimistic about the future. More than 65% respondents say they anticipate growth in the next two years. But this comes at a cost, with many companies restructuring to achieve growth in a difficult regulatory environment.
However, Cannings says the use of digital technology could be used to achieve growth.

“Digital technology and data analytics will soon shape everything from marketing to product development,” he says.

“The organisations that can embrace this change, rigorously challenge the way they do things; and keep the needs of the patient firmly in focus, will be the ones that win over the medium term.”

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