The Medicines Amendment Bill 2025
Our Managing Director, John Robson, presented to the Health Select Committee on Wednesday 4th June 2025 on the Medicines Amendment Bill 2025 (full text of our oral submission is [here], and in video [timestamp 2:06:37 [here]). The bill seeks to reform New Zealand’s Medicines Act 1981 to streamline access to medicines by introducing a verification pathway for overseas-approved drugs, expanding prescribing rights, and enhancing regulatory efficiency, particularly for unapproved medicines under Section 29. We are understandably supportive of the bill, but not for the reasons you might think.
There are many significant reasons to support this bill, and whilst most directly relate to our programme to commercialise our CAR T-Cell treatment for Diffuse Large B-Cell Lymphoma, there is also an aspirational goal: equitable access to many cutting-edge treatments for all Kiwis.
The bill introduces a pathway to fast-track medicines approved by recognized overseas regulators, reducing Medsafe’s assessment time and enabling access to novel therapies from overseas. But here is the catch; simple access to such therapies does not actually make them available. Whilst the Bill’s verification pathway allows medicines to reach New Zealand faster, this does not itself grant equitable access. The high cost point of these therapies, complex side effects requiring hospital care, and the need to travel overseas (or to ship a patient’s blood to a centralised facility overseas), create barriers, especially for Māori, Pacific, and rural communities. Simple approval does nothing unless you can deal to equity of access which is firmly rooted in price and the ability to travel.
That’s why BioOra is building a world-class manufacturing facility in Christchurch. Producing therapies locally isn’t just about approval; it’s about controlling costs and ensuring quality, as regulatory approval requires rigorous standards for both the therapy and its production site. New Zealand currently lacks the ability to manufacture complex therapies like CAR T-cell treatments, leaving us dependent on expensive global suppliers. We learned from COVID: local production is critical to guarantee your supply chain. BioOra, with the Malaghan Institute of Medical Research, is changing this with our unique, safer, and more affordable 3rd generation CAR T-cell therapy, now 25% through Phase 2 trials. We will forever be reliant on the prices demanded by overseas facilities unless we take agency over manufacturing. In short, people or their blood have to travel, and you have to pay a price dictated by a global supplier for the privilege.
We are in the unique position that the Malaghan Institute of Medical Research spearheaded research into a unique and patent-protected 3rd Generation CAR-T asset, which has the potential to offer a best-in-class safety profile, and we have developed an automated and lower cost manufacturing model that is scalable. It has taken years to get to this point, and today, we are focused on approval from Medsafe, our submission to PHARMAC for funding support, and how to ensure a robust delivery model exists for regional access.
But we can't delay. This is only one indication, and the questions are how do we bring the next CAR to market and how do we ensure our people can access the latest and most promising therapies at a price point that enables wide access? Our investors have been on the journey with us, and we have gone from 0 patients to 15 patients in 9 months, and we're accelerating as we go. We're building out the team, the facilities, the regulatory planning, the clinical delivery, and our partnerships.
We owe it to ourselves to take control of the future pathways for such therapies, and to ensure access for all. We need to back ourselves to be able to manufacture multiple therapies, and if the proposed changes to Section 29 could fast-track an ability for us to source other unique and approved therapies for local manufacturing, then we might just shave years off the regulatory journey, and add years to the lives of some patients. Working with the Malaghan Institute enables us to develop our own new therapies, and having access to global therapies that we can seek to refine and develop in partnership with them will ultimately save lives.
The ongoing research at the Malaghan Institute of Medical Research is only possible with the financial support of donors and supporters, and our own part to play in this is only possible with the support of our investors and shareholders. We have just opened our new investment round which will see us breaking ground on the new facility and preparing the pathway to deliver these therapies outside of the restrictions of a clinical trial, and directly into the hands of our doctors and nurses. Existing shareholders will receive direct notifications and access to the investment data room shortly, and new investment is restricted to wholesale investors only. Please email investments@bioora.com if you wish to be added to the wholesale pool for information as it is released.