Lavelle: Emerging policy barriers creating problems for biotech sector

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AusBiotech CEO, Dr Anna Lavelle, sat down to mark the launch of BiotechDispatch and discuss the organisation's priorities for the year ahead.

According to Dr Lavelle, the organisation she has led for almost ten years remains focussed on the commercial needs of its member organisations.

"What we're always trying to do is speak to the bottom line of our members," she says. "Our largest membership group are small-to-medium size enterprises and what they need from us are things they can't get on their own, such as a collective voice in policy discussions."

DSC_0854According to Dr Lavelle, representing AusBiotech members in policy discussions, with ministers, their advisers, the opposition, smaller parties, independents and the bureaucracy, means a focus on things such as foreign direct investment, the availability of venture capital, government investment, and policies that give companies relief, such as tax reform.

"One of our most important over-arching tasks is to build policy-makers' understanding of our sector," Dr Lavelle says. "A lack of understanding is sometimes reflected in policy, such as the recent changes to the R&D Tax Incentive and proposed reform of the tax treatment of employee share schemes."

On tax reform, AusBiotech remains nonplussed over the recent deal between the Abbott Government and the Palmer United Party on the R&D Tax Incentive that will see a retrospective cap on claims.

It has called for transitional arrangements but Dr Lavelle believes the reform reflects a fundamental misunderstanding of how innovation works and the inter-dependence of its different stages.

"One barrier in that chain of policy settings can have a significant and negative impact, and we are making the Government aware of the implications of this change," she told BiotechDispatch.

Another focus area is reform of the tax treatment of employee share schemes.

Changes by the former government in 2009 have had a particular impact on Australia's biotechnology sector, where shares are often used as an incentive for companies in their resource restrained pre-revenue phase.

Following its election, the Abbott Government reviewed the 2009 changes and in January released draft legislation that Small Business Minister Bruce Billson said would "unwind" the former government's changes.

AusBiotech has welcomed the Government's commitment to reform but questioned the draft legislation, particularly over its impact on member companies.

Dr Lavelle says the proposed reforms are "on the right track" but further change is required.

"Sweat equity is fair and particularly well-suited for the biotechnology sector, where companies are often established based on an idea with no short to medium term prospect of generating revenue," she says.

The challenge, according to Dr Lavelle, is that the proposed changes are only a "partial reversal" on 2009 that will exclude many biotechnology companies.

"Part of it is really good. Under the changes people get a 15 per cent discount on options and only pay tax on realisation, whereas before people were paying income tax when the shares were granted, and then capital gains on realisation.

"But the question is who qualifies? This is where it gets a bit grey," Dr Lavelle says.

Under the proposed changes, to quality companies must be less than ten years old, unlisted, and have turnover of under $50 million.

According to Dr Lavelle, "The ten years is tight for our sector because it can take 15 years to develop a new technology to the point it can be monetised, and the unlisted aspect will kill it for us because so many new biotechnology companies are forced to list early for capital.

"I know there is no enthusiasm in Canberra for carving our sectors but these aspects of the reform need to be reconsidered.

"It's just illogical that the proposed reforms would proceed as announced because so many small companies in the biotechnology sector simply will not qualify.

"We have proposed that listed companies, which are operating at a loss, should be included, or that they should include companies that qualify for the R&D Tax Incentive," Dr Lavelle says.

Other issues to keep AusBiotech busy include ongoing work on reform of the policy environment for clinical trials .

Four years after publication of the recommendations of the Clinical Trials Action Group and progress remains a challenge.

Dr Lavelle says everyone agrees on the need for reform, and the Government has established an advisory committee including sector representatives, but the split in responsibilities between the commonwealth, states and territories, makes progress very difficult.

"Thankfully, we came away from the last committee meeting thinking that, for the first time in years, progress might actually be made - the key is the timeline."

Events will again be a big feature of AusBiotech's year, with state-based events, AusMedtech in April, the Agriculture Bioscience International Conference in September, and its national conference in October.

The national conference, which returns to Melbourne, is pivotal for its member companies, according to Dr Lavelle, with so many reliant on partnerships with global technology companies.