1. INTRODUCTION AND SUMMARY
1.1 This submission on the Medicines Amendment Bill is made by The New Zealand Initiative (the Initiative), a Wellington-based think tank supported primarily by major New Zealand businesses. In combination, our members employ more than 150,000 people.
1.2 The Initiative undertakes research that contributes to developing sound public policies in New Zealand. We advocate for the creation of a competitive, open and dynamic economy and a free, prosperous, fair and cohesive society.
1.3 The Initiative’s members span the breadth of the New Zealand economy. Improvement in access to medicines is a matter of broad concern. The views expressed in this submission are those of the author rather than the New Zealand Initiative’s members.
1.4 We are very strong supporters of the intent of this legislation. That intent was best expressed in the coalition agreements that formed the government: “Require Medsafe to approve new pharmaceuticals within 30 days of them being approved by at least two overseas regulatory agencies recognised by New Zealand.”
1.5 Unfortunately, the Bill will not achieve the intent expressed in the coalition agreements that formed the government. Rather than automatically approve medicines already approved by trustworthy overseas regulators, it sets a fast-track approval pathway for a limited subset of medicines approved by those overseas regulators. It also provides Medsafe with ample opportunity to stop the clock on those approvals.
1.6 We believe there are two options for strengthening the legislation to achieve its desired objective.
1.6.1 The Bill could be amended to automatically approve medicines that have been approved by at least two trusted overseas regulators, under the conditions of the overseas approval relied upon. A medicine provided emergency use authorisation by two overseas regulators would here receive emergency use authorisation. Under this option, Medsafe could retain the option to block an automatic approval if it had specific cause for concern. Use of that veto would be regularly evaluated to test whether it should be retained, restricted, or removed.
1.6.2 The Bill could alternatively be complemented by an additional section 29 pathway for NZ unapproved medicines that have been approved, either fully or provisionally, by at least two trusted overseas regulators. That pathway would maintain current rules on supply chain documentation to ensure medicines are not counterfeit, that they were from batches that were approved as safe for sale in the authorised market, and that any coldstore
requirements were met during importation. Otherwise, those medicines would be treated as comparable to Medsafe-approved medicines. Requirements that medicines be imported for a particular named patient would be removed, as would 29(2) requirements documenting the medicines’ use. Currently, only a restricted set of medical practitioners are allowed to supply medicines under s29. That restriction would be eased for overseas-approved medicines.
1.7 Either option should achieve the intent of the legislation, strengthening access to medicines that have been proven safe by trusted regulators. Nothing in either option would prevent Medsafe from collaborating with foreign approval agencies to share the burden of assessing medicines.
