Manufacturers spend many millions of dollars researching, developing, testing and marketing their new products.
Agcarm believes these innovator companies are entitled to protect their new products from generics companies which quickly replicate and sell duplicate products.
We are asking for a fair go through data protection and patent protection.
Data Protection
Regulatory data is the research and test results generated by crop protection and veterinary medicine companies to prove the safety and efficacy of a product.
The research required for a product to become registered is very detailed and demands huge investment. The protection of regulatory data is therefore essential for innovation and development of new products.
Data protection laws in New Zealand are woefully inadequate.
Inadequate data protection laws are a disincentive to bringing new, innovative and more environmentally benign products to New Zealand. Therefore access to the latest active ingredients and their formulations are often lost to our farmers and growers in New Zealand.
Data is required by New Zealand regulators, such as the Environmental Risk Management Authority (ERMA) and the Agricultural Compounds and Veterinary Medicines Group (ACVM), for approval of agricultural compounds. But this information, which Agcarm members often invest millions of dollars to obtain, can then be copied by generics companies.
New Zealand offers no data protection for information supporting the registration of new uses and formulations of existing substances.
This acts as a disincentive to developing new uses for existing products. It is also a disincentive for companies to produce additional data to allow the continued sale of agrichemicals and veterinary medicines when they are reassessed.
Agcarm is campaigning for set periods of data protection. New uses and formulations, and reassessments of existing substances, which currently have no data protection period, should have 10 years of data protection. For innovative substances, or new organisms which have data protection, the period should move from five to ten years.
Data protection should be additional to the 20-year patent period.
Patents protect the invention, not the data required for pre-market approval. Patents and data protection should run concurrently meaning, in some cases, the data protection period will expire at the same time as the patent.
Agcarm is not asking for unlimited or infinite data protection.
Our members are seeking to strike that balance, between the rights of innovator companies to receive an acceptable return from their investment in innovative products, while working in a competitive market in which generic copies of their products keep prices down.
Patents
The Patents Bill, now back in the House, needs two major improvements.
The first focuses on allowing the term of a New Zealand patent to be extended.
In 1994, the term of a patent was extended from 16 years to 20 years, but at the same time a provision was repealed that would have allowed for a maximum term of up to 26 years in cases where regulatory delay had occurred.
Agcarm would like to see provisions in the Bill for extensions to the current maximum term.
This would make sense, particularly in our industry where regulatory conditions and product registration processes are not always straight forward, but R&D investment is significant and needs to be fully recouped.
Agcarm will oppose vigorously the existing ‘springboarding’ provision, which should be removed from the Bill.
Springboarding was introduced in 2002 without public consultation to allow Pharmac to facilitate more easily the introduction of cheaper, generic pharmaceuticals on to the New Zealand market.
However, springboarding has serious intellectual property implications for our industry and will pose significant commercial risks for our members.
It’s also at odds with what the United States and Australia do and we need to bear that in mind when we finalise legislation that affects companies operating in those parts of the world.
