Open consultation: Revision of the National Medicines Policy
The Ministry of Health (Department) has opened a public consultation on the review of the National Drug Policy (PNM). As part of the review, the Expert Advisory Committee (the Committee) is seeking comments on a number of proposals, including the possibility of expanding the definition of drug under the NIP to include medical devices and drugs. vaccines. The consultation is now open and will close on Friday, October 8, 2021.
The Ministry of Health (department) opened a public consultation on the revision of the National Medicines Policy (NMP). As part of the review, the Expert Advisory Committee (Committee) is seeking comments on a number of proposals, including the possibility of expanding the definition of drug in the NPM to include medical devices and vaccines. The consultation is now open and will close on Friday, October 8, 2021.
NMP plays an important role in facilitating access to medicines for all Australians. NPM has four main objectives, namely:
- rapid access to the medicines Australians need, at an affordable cost for individuals and the community;
- drugs meeting appropriate standards of quality, safety and efficacy;
- quality use of drugs; and
- maintain a responsible and viable pharmaceutical industry.
Since its introduction in 2000, many aspects of the healthcare landscape have changed dramatically. The Minister of Health has set up an Expert Advisory Committee (Committee) to lead the review of the NIP (Review).
What are the objectives of the Journal?
The objectives of the Journal are to:
- assess the current objectives of the NIP and determine whether to modify them or to include additional objectives;
- review the definition of drugs and determine whether the NIP should be expanded to include health technologies;
- assess the utility of NIP in the context of rapidly evolving treatment options, population changes, interconnected relationships and system-wide capacities;
- consider the focus of the consumer within the NPM and whether it captures the diversity of consumer needs and expectations;
- identify options to improve governance, communications, implementation (including enablers) and evaluation of the NIP; and
- review NPM partners and propose options to strengthen accountability, including addressing conflicts of interest.
We develop each of them in turn below.
Assessment of current NIP objectives
The department plans to update the NPM goals in support of its goal of “optimizing health outcomes for all Australians through a collaborative partnership with key stakeholders, with a particular focus on access people to medicines and their rational use ”.
The following principles are proposed for inclusion in the current objectives of NPM:
- Equity: All Australians enjoy effective, safe, high-quality and affordable access to medicines when needed, regardless of their background or personal circumstances.
- Consumer-centered approach: Consumers must be informed, engaged and empowered to participate in drug policy, recognizing their key role in achieving policy goals.
- Partnership-based: Establish and maintain active, respectful, collaborative and transparent partnerships, in order to harness the skills, experience and knowledge of stakeholders.
- Accountability and transparency: all stakeholders are identified and accountable for their responsibilities and actions to achieve or contribute to the achievement of policy objectives, within a transparent framework.
- Stewardship: All stakeholders have a shared responsibility to ensure that the objectives of the policy are achieved in an equitable, efficient and sustainable manner, as stewards of the health system.
Changing definitions of medicine
In the current version of Therapeutic Products Act, 1989 (Cth) “medicinal product” means: “therapeutic products (other than biological products) which are expected to perform or are likely to perform their intended principal action by pharmacological, chemical, immunological or metabolic means in or on the body of a human. NMP considers the term “drug” to include prescription and over-the-counter drugs, including complementary health products.
As part of the review, the committee is seeking comments on whether the current NPM definition of drugs should be broadened to include medical devices and vaccines. The rationale for expanding the definition of medicine stems from the emergence of new medicines and new medical technologies that blur the lines between medicines and medical devices (for example, with regard to diagnostic tests ). There would undoubtedly be regulatory implications as a result.
The usefulness of NMP
As part of the review, the Committee invites comments on gaps in the current policy framework and how the NIP can be updated to better respond to current and future changes in the healthcare landscape.
One of the main considerations is whether the NIP has been able to adequately maintain its relevance and respond to changes in the health landscape in light of significant advances in a number of key areas (e.g. biotechnology and medical science). This is particularly relevant with the current rollout of COVID-19 vaccinations for Australians.
In addition, the digital arena is also changing the way consumers access information on health-related products. Consumers are now increasingly informed about health products, leading to more informed discussions with health care providers about appropriate treatment options.
Consumer centricity and diversity
The review also aims to understand how NPM’s focus on consumer orientation and engagement can be enhanced.
Although the consumer is at the heart of the key objectives of the NPM, the consideration in the NPM of the diversity of consumers and their specific needs is insufficient.
An updated policy is expected to incorporate the voice of consumers into decision-making by:
- promote the understanding and engagement of consumers as active, empowered and informed participants in their care;
- provide timely, appropriate, targeted and personalized support to achieve optimal health outcomes; and
- promote equity of access to timely and affordable treatment, when, where and how it is needed.
The Committee also calls for consultations on whether there are mechanisms to strengthen the governance arrangements of the NPM. Since 2000, there are now numerous formal agreements between key partners and intergovernmental funding agreements between Commonwealth and State governments. In addition, a number of committees and organizations have also been established, including the Pharmaceutical Benefits Advisory Committee and each of its sub-committees and the TGA Statutory Advisory Committees. The objective of the review is, among other things, to ensure greater transparency and accountability for all partners involved in the implementation of the NIP.
Review of NMP partners
Feedback from stakeholders indicated that there should be a more structured, transparent and accountable evaluation process in each of the groups responsible for advancing the political objectives of the NIP. Stakeholders are invited to give their views on how the NPM partnership approach should be defined, how the partnership approach can be improved and how the NPM should be updated to support greater accountability among NPM partners.
The consultation to provide feedback on the review ends on October 8, 2021. Please see the Department of Health website for more information.1