The Department of Health (Department) has opened a public consultation on the review of the National Medicines Policy (NMP). As part of the review, the Expert Advisory Committee (Committee) is seeking feedback on a number of proposals, including the possibility of expanding the definition of medicine under the NMP to include medical devices and vaccines. The consultation is now open and will close on Friday, 8 October 2021.
The NMP plays an important role in facilitating access of medicines for all Australians. The NMP has four main objectives, being:
- timely access to the medicines that Australians need, at a cost that individuals and the community can afford;
- medicines meeting appropriate standards of quality, safety and efficacy;
- quality use of medicines; and
- maintaining a responsible and viable medicines industry.
Since its introduction in 2000, many aspects of the health landscape have changed significantly. The Minister for Health has established an Expert Advisory Committee (Committee) to lead the review of the NMP (Review).
What are the aims of the Review?
The aims of the Review are to:
- evaluate the current NMP objectives and determine whether these should be modified or additional objectives included;
- consider the definition of medicines and whether the NMP needs to be expanded to include health technologies;
- assess the NMP’s utility in the context of rapidly evolving treatments options, population changes, interconnected relationships and system-wide capacities;
- consider the centricity of the consumer within the NMP and whether it captures the diversity of consumers’ needs and expectations;
- identify options to improve the NMP’s governance, communications, implementation (including enablers) and evaluation; and
- review the NMP partners and provide options for building greater accountability including addressing conflicts of interest.
We expand on each of these in turn below.
Evaluation of current NMP objectives
The Department is considering to refresh the objectives of the NMP in support of its goal to ‘optimise health outcomes for all Australians through a collaborative partnership with key stakeholders, focusing especially on people’s access to, and wise use of, medicines’.
The following principles are being proposed for inclusion into NMP’s current objectives:
- Equity: all Australians receive effective, safe, high-quality, and affordable access to medicines when needed irrespective of background or personal circumstance.
- Consumer centred approach: consumers should be informed, engaged, and empowered to participate in medicines policy, recognising their key role in supporting the achievement of the policy’s objectives.
- Partnership based: establish and maintain active, respectful, collaborative, and transparent partnerships, to harness stakeholders’ skills, experience, and knowledge.
- Accountability and transparency: all stakeholders are identified and accountable for their responsibilities and actions towards delivering or contributing to the achievement of the policy’s objectives, within a transparent framework.
- Stewardship: all stakeholders have a shared responsibility to ensure that the policy’s objectives are met in an equitable, efficient, and sustainable manner, as stewards of the health system.
Amendment to definitions of medicine
In the current version of the Therapeutic Goods Act 1989 (Cth) ‘medicine’ means: ‘therapeutic goods (other than biologicals) that are represented to achieve, or are likely to achieve, their principal intended action by pharmacological, chemical, immunological or metabolic means in or on the body of a human. The NMP considers the term ‘medicine’ to include prescription and non-prescription medicines, including complementary healthcare products.
As part of the Review, the Committee is seeking feedback on whether the current NMP definition of medicines should be expanded to include medical devices and vaccines. The rationale behind the expansion of the definition of medicine stems from the emergence of new drugs and novel medical technology blurring the boundaries between medicines and medical devices (for example, in relation to diagnostic tests). There would, undoubtedly, be regulatory implications flowing from this.
As part of the Review, the Committee is seeking feedback on the gaps in the current policy framework and how the NMP can be updated to better address current and future changes in the health landscape.
One of the primary considerations is whether the NMP has been able to adequately maintain its relevance and respond to changes in the health landscape in light of the significant advancements in a number of key areas (e.g. biotechnology and medical science). This is particularly relevant with the current rollout of COVID-19 vaccinations to Australians.
Further, the digital arena is also changing the way consumers access information about health related products. Consumers are now becoming increasingly knowledgeable about health products leading to more informed discussions with healthcare providers on appropriate treatment options.
Centricity and diversity of the consumer
The Review is also aimed at understanding how the NMP’s focus on consumer centricity and engagement can be strengthened.
Although the consumer is at the heart of the NMP’s key objectives, there is inadequate acknowledgement in the NMP of the diversity of consumers and their specific needs.
It is intended that an updated policy should incorporate the consumer voice in decision-making by:
- promoting understanding and engaging consumers as active, empowered, and informed participants in their care;
- providing prompt, appropriate, targeted, and tailored support to achieve optimal health outcomes; and
- promoting equity of access to timely and affordable treatment, when, where and how it is needed.
The Committee is also seeking consultation on whether there are any mechanisms to strengthen governance arrangements for the NMP. Since 2000, there are now many formal agreements between key partners and inter-governmental funding agreements between Commonwealth and State Governments. Further, a number of committees and organisations have also been created, including the Pharmaceutical Benefits Advisory Committee and each of its sub-committees and the TGA’s statutory advisory committees. The aim of the Review is to, amongst others, ensure greater transparency and accountability for all partners involved in the implementation of the NMP.
Review of NMP partners
The feedback from stakeholders indicated there should be a more structured, transparent and accountable evaluation process into each of the groups responsible for advancing the NMP’s policy objectives. Stakeholders are being asked to opine on how the NMP’s partnership-based approach should be defined, how the partnership approach can be improved and how the NMP should be refreshed to support greater accountability amongst the NMP partners.
The consultation to provide feedback on the Review closes on 8 October 2021. Please refer to the Department of Health’s website for more information.1