Therapeutics Bill: a step back?
Bill may curb rights to prescribe atropine

Therapeutics Bill: a step back?

May 13, 2019 Heather Douglas

Concerns are being raised that the Therapeutic Products Bill, currently going through Parliament, may result in an unintended step back for New Zealand optometrists’ hard-won rights to prescribe eye-related therapeutics directly for patients.

 

The draft Bill has been designed to replace the Medicines Act 1981 and its associated regulations and establish a new regulatory scheme for therapeutic products. But the New Zealand Myopia Action Group (NZMAG), which includes optometrists, ophthalmologists and other health professionals, is concerned the Bill will remove optometrists’ ability to prescribe low-dose atropine to manage myopia.

 

In its submission, NZMAG writes its concerns centre around section 75 of the Bill, which limits the use of off-label medicines and those without product approval in New Zealand to medical practitioners. “We believe that optometrists (with therapeutic prescribing rights), not just medical practitioners, should be able to issue a special clinical needs supply authority (SCNSA) for medicines that do not have a product approval in New Zealand, if these fall within an optometrist’s scope of practice,” said NZMAG.

 

NZMAG spokesperson, optometrist Alex Petty, said the Bill in its current form would be a huge step back for myopia management in New Zealand. Others questioned, who didn’t wish to be named, agreed, saying it would be a huge step back for all eye care professionals if optometrists were forced once again to seek permission from GPs or ophthalmologists before being able to prescribe certain eye-related therapeutics, especially as many GPs have little understanding of the medicines involved compared with optometrists.

 

In its submission, NZMAG drew attention to the global rise in myopia, which is now reaching epidemic proportions in some countries. “One of the key components of myopia management around the world and in New Zealand is the prescription of low-dose atropine eye drops for at risk children with progressive myopia,” it said.

 

As well as NZMAG, NZ Optics understands the New Zealand Association of Optometrists (NZAO), the University of Auckland and possibly the Cornea and Contact Lens Society of New Zealand (CCLSNZ) made submissions on this issue by the closing date of 18 April.

 

As stated in the Bill, The Medicines Act 1981 is becoming ever less fit for purpose. It is dated, inflexible and hard to use and has significant gaps in coverage (eg, it provides no pre-market controls on medical devices). It is also prescriptive and prevents regulatory efficiencies; and makes it difficult for some cell- and tissue-based products to come to market.

 

Attempts at legislative change in this area date back to the late 1980s and early 1990s when reform was first proposed. For much of this time, efforts focused on establishing a joint regulatory scheme and agency (the Australia New Zealand Therapeutic Products Agency, ANZTPA) with Australia. Work on the Therapeutic Products Bill began in 2014, when this idea was finally dropped.

 

A lot of work, however, remains to be done. The Bill sets out the legislative framework for the new regulatory scheme, but the detail of how this scheme will work in practice (ie, the regulations, rules and notices) still needs to be developed. Further consultation opportunities will follow during the select committee process and when the regulations, rules and notices are developed.