By Dr. George Slim, President of NZBIO

Is developing new drugs too difficult?

This is a question that we often get asked at NZBIO. Every new drug that enters clinical trials has about a 1-in-10 chance of success. The drugs that do make it all the way are typically in the research and development phase (R&D) for more than a decade at a cost of more than a billion dollars, which clearly requires international investment for drug candidates discovered in New Zealand. So much time, So much money, so many failures in R&D, so why do it?

At the Biotechnology Institute Organization conference in June, NZBIO had the opportunity to talk with researchers, investors and managers of international research organizations and drug companies. The one lasting impression was everyone’s passion for finding a solution. Their goals varied from pain relief to complete cures; the conditions targeted ranged from flu to common diseases to cancers.

All were passionate; all were seeing failure as a step toward the ultimate goal of a cure. But beyond this passion there needs to be an ability to recoup investment, developing profitable companies that can afford investment in R&D. Without an ability to protect this innovation, there will be limited-if any- R&D and developing life-saving, innovative medicines will become impossible. Unless the system works internationally, New Zealand will not be able to participate in the industry.

Last week, I spoke to the negotiators at the 15th Round of the TPP negotiations in Auckland, New Zealand. I reinforced the importance of having strong IP protection in the agreement that supports innovation across the board and will allow the development of new medicines and new cures. At NZBIO, we believe in a global IP system that is rigorous and well-respected internationally; one that is fair to all types of innovators and provides certainty without recourse to litigation.

In order to protect these fundamental principles, we believe the right TPP agreement will include patent term extensions, (NZ and Australia currently have none) that take into account delays in patent grant and regulatory approval. This 21st century agreement will also ensure data exclusivity so that companies can recoup the costs of gathering data for regulatory purposes without the regulations being a barrier to legitimate entry of medicines to markets after the patent term has expired. NZBIO also expects the agreement to include a reduction and clarification of exclusions of patentable subject materials.

This is not just the view of “Big Phrma” as it is often criticized. As a representative of many small domestic innovators- biotech companies that span industries from agriculture to research to government, we are committed to providing new innovative and affordable medicines to the consumer but we can only do this when our IP is protected both at home and especially globally.

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