PERTH, Australia – Although industry stakeholders were generally supportive of New Zealand's Medicines and Medical Devices Safety Authority (Medsafe) proposed changes to the reclassification system for drugs in New Zealand, most vehemently opposed the idea of posting completed applications on the Medsafe website, citing competitive intellectual property concerns.

The agency said it sought to ensure the process for classifying drugs was easier to understand and more transparent. It said it would publish complete applications unless a specific request is made to withhold information.

"Applications may include supporting documents or appendices such as training materials and screening tools. The applicant should prepare these materials with the expectation that the information will be made publicly available," according to the final guidance.

Sponsors may specifically request that some information is not released but only to the extent permissible under the Official Information Act 1982 (OIA), which upholds transparency in the public sector. The principle of the OIA is that "information shall be made available unless there is a good reason for withholding it," the agency said.

If a sponsor considers that material provided in the application should not be made publicly available, it must clearly state this in the application and quote the relevant sections under the OIA that the applicant considers to justify its exclusion.

New Zealand's Medicines Act 1981 defines three classification categories for medicines: prescription medicine, restricted medicine and pharmacy-only medicine.

The Medicines Classification Committee (MCC) is a ministerial advisory committee that makes recommendations to the health minister regarding the classification of drugs as well as the reclassification of drugs.

Publishing bad for business?

The New Zealand Self Medication Industry Association (NZSMI) said in its comments that it had "deep concern" regarding the publication of the application materials due to intellectual property concerns. It said it could provide examples where competitors gained access to such applications.

"Collectively these isolated, but highly contentious, examples are creating a global perception that New Zealand is not the place to innovate or progress when it comes to bringing improved formulations, new molecules or new administration techniques to the public," NZSMI said.

"NZSMI members fully understand and applaud the need to present research, evidence and proposed protocols to the MCC and Medsafe when seeking medicine classification, but not at the unreasonable cost of full public disclosure of highly developed intellectual property to all."

Echoing similar sentiments, the Pharmacy Guild of New Zealand strongly opposed posting the application, reference lists and training materials on the Medsafe website.

It believes the changes would result in a "disincentive for companies and organizations submitting proposals for the reclassification of medicines in New Zealand," which could have future implications for access to medicines.

"Reclassification applications contain intellectual property and require a tremendous amount of background research and resource," and publishing this information makes it accessible globally, it said, adding that this process has already resulted in "plagiarized reclassification applications being submitted to the MCC, and other applications being withdrawn."

If multinational pharma companies are discouraged from making new applications, there is a likelihood that reclassifications to restricted or pharmacy-only listings will cease, the guild said, which would ultimately limit improved access to medicines and be a detriment to the New Zealand health system.

The guild suggested that an executive summary of the reclassification application would be sufficient to publish on the Medsafe website, and that members of the MCC "have the skillsets required to make decisions on the material provided with the applications."

Healthcare provider Green Cross Health also was concerned about supporting documents being made publicly available. It did not have concerns with documents being shared with the committee, but it suggested that perhaps documents could be shared with medical organizations instead.

Risk-benefit considerations

The guidance provides more information on the parameters that the MCC considers when making drug reclassification decisions.

For example, applicants are encouraged to make a risk-benefit assessment of the medicine proposed for reclassification before submitting an application to the MCC, and a risk-benefit assessment decision tool is provided in the final guidance.

Risk considerations include unintended misuse, accidental ingestion, intentional overdose, worsened outcome due to self-management and communal harm. The communal harm risk is new. Benefit considerations include improved access, improved clinical outcomes, improved public health and economic benefits.

NZSMI said the term "community harm" needs to be specifically defined. It asked whether improved access would be considered a community benefit.

Medsafe does not meet with companies to discuss reclassification of their drugs in advance, because such a meeting "could be considered a conflict of interest for the Ministry of Health members of the MCC."

The MCC is comprised of two nominees from the New Zealand Medical Association and the Pharmaceutical Society of New Zealand, and two members of the Ministry of Health, one of whom is appointed as chairperson.

In determining whether a drug is suitable for non-prescription sales, the MCC considers whether the medicine shows substantial safety in preventing the management of the condition or symptom under consideration. It also considers whether conditions or symptoms can be diagnosed and managed by a pharmacist or be easily self-diagnosed and safe-managed by a consumer.

The MCC will also consider the classification of the drug in Australia, since the two countries have been working toward harmonization of classification decisions in both countries.

Proposals will be reviewed by the Pharmacy Council/Pharmaceutical Society of New Zealand to determine what additional training or tools pharmacists might require to prescribe pharmacist-only medicines.

The Pharmaceutical Society of New Zealand (PSNZ) suggested that companies would likely see training information as sensitive, and it recommended that it and the Pharmacy Council review training materials, rather than having the MCC post these on the website. The two groups could then deliver recommendations to the MCC.

It takes about six months from the time an application is lodged until a decision is made, and it may take an additional six months to amend labeling to reflect classification changes.

Sponsors may observe the MCC meetings, which are held under Chatham House Rules. Meeting minutes are posted on the Medsafe website as soon as recommendations are made.

The New Zealand Medical Association said it welcomed the addition of the "communal harm and/or benefit" parameter, because the change would "enable the MCC to take into account the effects of reclassification on aspects such as continuity of care, fragmentation of care and missed opportunities to address other health issues."

The association said it welcomed the inclusion of the Pharmacy Council/Pharmaceutical Society to determine whether screening tools or training are required for pharmacists as part of the decision to reclassify a drug.

However, it suggested that allowing sponsors to submit their applications directly to the Pharmacy Council/Pharmaceutical Society for review and endorsement before the submission to the MCC could represent a potential conflict of interest.

The Pharmacy Guild said it supported the joint decision-making framework of the Pharmacy Council and the Pharmaceutical Society of New Zealand.