It’s great to see CHPNZ members aligned with our thinking about the Therapeutic Products Bill. Thanks to Pharmacy Today for allowing us to republish the story below from Douglas Pharmaceuticals managing director Jeff Douglas, who says the Therapeutic Products Bill will create unnecessary red tape. We absolutely agree.
Our key platforms around the Therapeutic Products Bill are:
- Risk appropriate regulation
- Regulated timeframes for regulatory processes
- Equivalence to international regulators (harmonisation)
- External inputs via committees to the regulator
Therapeutic Products Bill creates unnecessary red tape says medicines exporter
New Zealand’s largest medicines exporter, Douglas Pharmaceuticals, has hit out at the Therapeutic Products Bill saying it will create unnecessary red tape for exporters.
The bill, which replaces the Medicines Act 1981, passed its second reading on 29 June when Parliament voted to approve numerous recommendations from the health select committee.
Labour and the Greens had the numbers to pass the bill 74 to 42 in the House, while National, ACT and independent MP Elizabeth Kerekere voted against it.
The bill aims to require medicines manufactured in New Zealand to have export authorisation before they can be sold overseas. Export authorisations are to be presided over by a new regulator and companies manufacturing medicines for export will be required to convince the regulator of their products’ safety, quality and efficacy.
Companies already need export permits and follow rules required by the countries exported to, and Douglas Pharmaceuticals managing director Jeff Douglas says the additional requirements will make this harder.
The bill will add complexity and significant time and costs, plus unnecessary paperwork, Mr Douglas says in a media release.
“All of Douglas’ exported products are required to meet the stringent requirements of regulators around the world, including the European authorities and the US FDA,” he says. Mandatory export authorisation is “unnecessary” to achieve the bill’s purpose to promote, protect and improve the health of all New Zealanders.
“If this bill is passed in its current form, it risks significant economic harm to those who export therapeutic products, at a time when New Zealand needs the industry most.”
Numerous changes
Aside from the aspects of the bill dealing with exporting, the health select committee made numerous recommendations, including excluding rongoā Māori from the legislation and provisions affecting cancer patients, advocacy groups and small-scale businesses. Changes include:
Rongoā Māori
The original draft sparked concerns about rongoā Māori falling under the power of the legislation, with some practitioners likening it to the Tohunga Suppression Act 1907.
A major theme from critics was that rongoā Māori must stay under Māori guardianship, not be governed by Parliamentary rules. It was alleged the original bill potentially breached Te Tiriti o Waitangi and failed under the Waitangi Tribunal findings in Wai 262 (claims about the place of Māori culture, identity and traditional knowledge).
The RNZCGP, the College of Nurses, Nurse Practitioners NZ and the National Party were among those calling for exclusion of rongoā Māori from the bill.
Associate health minister (Māori) Peeni Henare says Māori will retain determination around what rongoā means to them and who is a practitioner.
Regulation will apply when products are made for commercial wholesale or export but, as most rongoā practitioners don’t operate in that way, it shouldn’t affect day-to-day practice, Mr Henare says in a media release.
Concerns remain over the extent of the exclusion, and what will constitute commercialisation.
Importation
The bill aimed to ban importation of prescription medicines, in a bid to protect consumers from unknowingly purchasing unsafe or ineffective products from dodgy online sellers.
However, submitters highlighted the original provisions would stop cancer patients from buying generic cancer medications cheaply overseas, and said a requirement to bring only three months’ supply of a medicine into the country in personal luggage would be expensive and impractical.
The committee recommended removing the importing ban, and instead adding safeguards, including a requirement the drug be prescribed by a New Zealand prescriber for use within New Zealand.
Natural health products
Vitamin and mineral supplements, herbal remedies and probiotics were all listed as natural health products covered by the regulatory framework of the proposed bill.
Many natural health product manufacturers are small scale and work out of their own homes, selling locally at places like farmers markets, leading to concerns that the cost of compliance could put them out of business. health minister Ayesha Verrall agreed, saying regulation needs to be proportionate to risk.
Small-scale natural health product manufacturers won’t need to obtain a product authorisation or manufacturing licence under the bill if their goods are made and supplied in person to customers in New Zealand.
Advertising
Patient advocates raised concerns about the bill’s defining “advertisement” as communication for the purpose of promoting the product in any way whatsoever.
There were fears the law would prevent people from fundraising for medicines on Givealittle, or stop advocacy groups lobbying governments and Pharmac to fund particular drugs.
It was suggested the bill’s language could also limit some news reporting.
This now looks likely to be changed, with Dr Verrall saying the Government “never had any intention” to restrict Givealittle pages.
Definitions
The RNZCGP called for the medicine groups to be renamed, to avoid the confusion emerging between prescribers “due to associating medicines with a location (pharmacy) when they could be available elsewhere or linked to a particular profession (pharmacist-only)”.
Additionally, the College of Nurses and Nurse Practitioners NZ called for “medical practitioner” to be replaced with “authorised health practitioner” throughout the bill, saying it is “critical patient care and access is not impeded in the new legislation by using a limited definition of medical practitioner” that excludes nurse practitioners.
It is not clear whether the select committee accepts the need for this change, but it uses the term “health practitioner” throughout its 286-page report.
*Additional reporting by New Zealand Doctor Rata Aotearoa deputy editor Patrice Dougan
