McKeon Report echoes industry’s calls

Amid the raft of federal government consultations and reviews in recent months - a record number of which impact biotechnology - the Strategic Review of Health and Medical Research in Australia has released its final report, echoing industry’s calls for commercialisation, clinical trials and IP support.

AusBiotech and the biotechnology industry commend the review’s report, also known as the McKeon Report, as a well-articulated plan to build our nation’s healthcare over the next decade. In particular, the industry has warmly welcomed the report’s recommendations in regard to strengthening translation (commercialisation) of research, support to strengthen and protect ‘valuable’ intellectual property and a call to fast-track reforms to the clinical trials system.

The strengthening of commercial pathways to ensure the translation of research outcomes into health and economic benefits for the Australian community is a key element of the report, which recommends that funding address the twin ‘valleys of death’ in commercialising research and calls for the establishment a Translational Biotech Fund. The fund is aimed at early-stage development and is suggested to be worth $250 million, funded by the Australian Government and the private sector on a one-to-one matching basis.

The report’s recommended accelerated improvements to Australia’s clinical trials system aim to encourage global investment in R&D and lead to a better and more efficient healthcare system. The federal government recently announced $9.9 million over five years to boost opportunities for the Australian pharmaceutical industry by expediting the recommendations from the Clinical Trial Action Group (CTAG) Report - aimed at advancing Australia’s position as a leader in clinical research and improving our attractiveness as a destination for clinical research investment.

The Australian pharmaceutical industry has a positive outlook - exporting around $4 billion per year, employing over 40,000 people and investing more than $1 billion a year in R&D - but is facing rising and varying costs between clinical trial sites and jurisdictions, delays in approving trials and difficulty recruiting patients. Australia has traditionally been a destination of choice for the conduct of clinical trials; however, the country’s competitive advantage has declined over the last five years.

The federal government’s funding support will be dedicated to addressing the issues, such as the standardisation of the costs of clinical trials; developing a web portal for clinical trials; improving clinical trial conduct and timeliness of governance approvals; and a nationally consistent approach to clinical trials.

AusBiotech also commends the McKeon Report’s support to “protect valuable intellectual property”, which is in stark contrast to last week’s release of the Draft Report from the government’s Pharmaceutical Patents Review, which argues for a reduction to the five-year extension of patent terms available in Australia that compensate for regulatory delays.

The report says: “The best way to protect valuable IP is by ensuring Australia’s IP system is strong, stable, predictable and harmonised with international best practice. This cannot be achieved if policymakers implement undesirable reforms, such as the proposals to ban patents on biological materials and make it easier to obtain compulsory licences. It also cannot be achieved if efforts to harmonise IP standards with global best practice are inconsistent.”

Dr Anna Lavelle, the CEO of AusBiotech, said: “Extensions to the patents for innovation healthcare technologies are important when, as is often the case, the regulatory and reimbursement processes consume years of patent life.

“The government’s own standard for an effective patent life is understood to be 15 years, but nearly half of Australian pharmaceutical products that applied for a patent extension are falling short of that.

“Industry’s investment, as an important and majority funder of health and medical research in Australia, will diminish if there is a weakened IP system.

“Overseas companies may simply stop bringing their R&D investment dollars and products to Australia, and Australian companies may well take their trials and investment overseas.”

The full text of the report can be found here.