Patent amendment bill could kill access to new medicines

Banning patents on biological agents could see capital for innovative medicines dry up.

Read the argument for the proposed legislation

No one can deny that improved medical treatments and equity of access to them are essential to improving our community’s quality of life. Unfortunately, the current patent amendment bill threatens to block these goals.

Research translation involves optimizing the production of new medicines and lengthy pre-clinical and clinical testing to determine whether new medicines are safe and effective.

The community should demand nothing less. In many cases, the process of translation takes years or decades and many hundreds of millions of dollars.

This places research translation beyond the reach of academia, philanthropy and government, leaving only the private sector capable of making investments on the scale required.

This reality means that we must work with the private sector if we want the potential of life-changing discoveries to be realized.

It also means that the private sector must be able to generate a return on its investment.

The protection afforded by patents is an important mechanism by which investors are provided time to reap that return, so they can make investments in new medicines.

Given the central role the Patents Act plays in enabling investment and bringing new therapies to market, we must demand that any proposed amendments to the current act are clear in their intent; precise in their effect; and that the burden of proof that the benefits of the amendments vastly outweigh their potential disadvantages is overwhelming.

What is the problem advocates of the amendment seek to fix and what solution do they propose?

Quoting from the explanatory memoranda (1) _“The purpose of this Bill is to advance medical and scientific research and the diagnosis, treatment and cure of human illness and disease by enabling doctors, clinicians and medical and scientific researchers to gain free and unfettered access to biological materials, however made, that are identical or substantially identical to such materials as they exist in nature.”

Quoting from the proposed amendment itself (2) ; the solution is to expand the definition of non-patentable inventions from “human beings, and the biological processes for their generation” to additionally include “biological materials including their components and derivatives, whether isolated or purified or not and however made, which are identical or substantially identical to such materials as they exist in nature”, with biological materials defined as “DNA, RNA, proteins, cells and fluids”.

The “straw-man” - patents stifle creative medical research

First, let us consider whether the patenting of biological material, or indeed any other patents has hindered medical and scientific research.

In our combined experience - having worked for decades in major centres of medical research in Australia, the United States and Europe - the answer is a resounding no.

The vast majority of Australian medical researchers continue their programs without concern for patents.

With more than 11,000 patents being issued every year and more than 75,000 researchers in Australia, if patents, of any type, hindered public research, we would expect to see a myriad of infringement notices and court cases.

Where are they? The answer is they have not occurred because overwhelmingly research takes place without paying any heed to patents. It is a non issue.

Advocates of the amendment paint a picture of the devastating impact of patents on medical research, which is a complete distortion of reality. This argument is a straw man.

The dangerous fallacy that banning patents on biological materials will enhance access to life-saving diagnostics and treatments

We all agree that broad access to new ways of diagnosing, treating and curing diseases is desirable.

However, it is naive in the extreme - and ultimately placing patients’ lives at risk - to be advocating that this will be achieved by banning the patenting of biological materials. Quite the reverse!

By banning patents on biological agents, the capital required to transform innovations into products as varied as statins, taxol, filgrastim, sargramostim, rituximab, Herceptin and Gardasil will dry up.

As capital dries up, the pipeline of new products that treat the untreatable and prevent the unpreventable will slow to a trickle, and with it will dissipate the hopes of patients.

The way forward

The amendments currently being considered, and which will exclude biological materials from consideration from the patent act, fail three tests.

Their intent is misguided; their effect is far-reaching and unpredictable; and while there is no evidence that they will lead to improvements in patient care, there is a major concern that the reverse is true.

The amendments should be withdrawn immediately and, if not withdrawn, resoundingly defeated in Parliament.

There are very real challenges facing the health care sector - challenges such as the high cost of new genetic tests and new pharmaceuticals prohibiting widespread availability; and the escalating cost of healthcare as a percentage of Gross Domestic Product (GDP).

These are important issues but they are issues that can be dealt with by mechanisms, such as invoking Crown use provisions, compulsory licensing or Commonwealth acquisition.

Likewise, if access to affordable diagnostic tests is a major concern, then surely this can be addressed via an arrangement similar to the Pharmaceutical Benefits Scheme (PBS).

The PBS sets a precedent for controlling drug prices and this approach could extend to diagnostics. Let’s focus on real solutions to real problems.

Read the argument for the proposed legislation

Do you think patenting of genetic and biological materials should be permitted?

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