Association Focus In 2024: Self-Care, Sustainability And Prospects For Political ‘Reorientation’

Two themes that are central to the consumer health industry are environmental sustainability and driving efforts to achieve Universal Health Coverage (UHC). These aspects are crucial to reconfiguring how we see self-care.

There is an inextricable link between climate change and the health of populations, and the scale and speed of change that we need is only possible if all relevant actors come together and focus on efficacy and long-term impact.

In 2024, we will be building on the critical action that we achieved across our two environmental priority areas: plastics and packaging and CO2 footprint. We will engage with stakeholders around blister packs and sustainable packaging for non-prescription medicines and food supplements and to further research recycle-ready packaging. We will also build on our supplier guidance for supply chain and greenhouse gas emissions.

Over the next year, we will continue to advocate for a WHO Resolution on Self-Care that fully embeds self-care into the international framework for UHC by 2025. A resolution on self-care would provide a framework for its integration into national health systems, promote awareness and political commitment, and mobilize resources for evidence-based interventions.

We need to strengthen overall health systems. A sharp focus on UHC across the international healthcare community clearly enables this.

… important changes in the legislative environment for human medicinal products in the European Union.

Still, before the elections to the new European Parliament in June 2024 we have unfortunately to assume that the revised directive on urban waste water treatment will be adopted. It will have huge cost implications for manufacturers. This contrasts with the objective to strengthen the pharma industry in Europe.

In the same sense some proposals for the revision of the general EU pharma legislation should not be pursued. Bringing more medicines under prescription status or even eliminating categories of medicines such as homeopathic medicinal products will only create additional costs for the health care systems without any benefit for the citizens.

It is good to see EU and national pharma strategies with an overall right mindset now in place. What we urgently need in 2024 is the willingness to put such strategies into meaningful actions. There are many opportunities to reduce administrative burdens which would strengthen the resilience of the supply chain. This also applies to medical devices which suffer from unbalanced EU regulation. Amendments are urgently needed in the new year.

… a new way of looking at our products and sector.

At European level, the Pharmaceutical Strategy will reflect and formalize the pressing issues for policymakers and the public, such as safety, shortages, as well as environmental considerations. This new framework will set the rules for the decades to come for OTC medicines. It also confirms that the benefits as well as risks are no longer considered only from an individual perspective (eg, for a given patient) but also from a collective perspective (including the societal and environmental impacts).

Similar concerns will also drive the French agenda for all selfcare products through sector-specific decisions but also through the general framework applicable also to self-care products. Increasingly, self-care products will no longer be regulated only by sectorial regulation but also by general regulation, pushing our sector to consider a wider range of regulation as well as to interact with additional (and non-health/food related) authorities, such as environmental authorities.

With success comes responsible behaviors: as the market of food supplements grows, so do the interest and scrutiny of authorities, requiring responsible conducts from all players to remain credible stakeholders (such as in 2023 when the authorities allowed use of the term ‘probiotics’ to identify a category of food supplements based on sectorial guidelines). With the change of competent authority regulating food supplements effective as of 2023, the Ministry of Agriculture has planned to revisit the national framework for food supplements.

Environmental and safety considerations are behind the French pilot project of ePILs (electronic Patient Information Leaflets), in which some OTC medicines will be able to take part and which will be launched in 2024.

Finally, as France experiences more severe GP shortages, one can expect greater self-care practices through community pharmacies, facilitated by the deployment of new services around self-care (eg, point-of-care testing for sore throat and cystitis). More than ever, it will be essential to make visible self-care products’ value to the health continuum, but also of the self-care industry as a whole to the national economy.

For the ASSGP and its members, 2024 will be a year in which we want to take self-medication and its integration into the Swiss healthcare system a decisive step forward. Our study planned for 2024 to analyse the economic and social impact and potential of self-medication in Switzerland will provide an important basis for this. We are also pleased that the Swiss government has announced that it will resume negotiations on bilateral relations with the EU in 2024. The fact that, as announced, the relevant points are to be negotiated by the end of 2024 and that sustainable, harmonized relations between the EU and Switzerland will soon be re-established is of central importance for our industry.

… collaboration.

In an industry the size of ours, with so many stakeholders, it’s not always possible to gain consensus on an issue. But it’s worth trying. Our CEO recently published an essay in which he pointed out that part of the art of association work is knowing what tact and tone to take when advocating for a particular position. Sometimes, for example, thoughtful, well-laid-out criticism of a proposed regulatory action is preferred over being generally confrontational. At the risk of sounding cliché: be part of the solution, not the problem.

 In 2023, CRN took this approach, for example, when we offered sound counterpoints to congressional research data with regard to the cost of including dietary supplements in FSA/HAS programs [pre-tax accounts for healthcare related expenses], or when we pointed out flaws in guidance issued by the FTC. The best advocacy is when your criticism is constructive and ultimately leads to a collaborative posture, from which you are recognized as responsible, reasonable and ready to broker a solution.

 In 2024, as DSHEA turns 30, collaboration and consensus – rather than conflict –will define success as we look to improve the regulation of our industry.

... navigating an inconsistent and challenging-to-predict regulatory environment, with the consumer healthcare industry facing regulatory headwinds that demand strategic solutions.

FDA’s recent actions that take aim at certain ingredients, particularly on efficacy grounds, is a significant development that is impacting markets and consumer trust. In addition to the reorganization of offices within FDA, we must also consider the impact of leadership transitions. In the states, the consumer healthcare industry continues to be challenged by a patchwork of inconsistent policies. We anticipate additional efforts to enact extended producer responsibility (EPR) initiatives in some states, and efforts to impose age restrictions on weight-loss supplements, in others. CHPA also remains concerned with any future state action to ban FDA-approved ingredients, such as TiO2. Although well intentioned, these legislative initiatives could create unintended consequences for millions of consumers.

Despite these regulatory and legislative challenges, the industry continues to experience growth and innovation and we hope to see the benefits of OTC monograph reform, enacted in 2020, now that FDA has built systems and hired staff necessary to implement the law. The role of self-care has never been more important and is broadening to many new categories, including at-home testing, OTC hearing aids, oral contraceptives, and emergency naloxone. CHPA will continue to advocate for public policies that help consumers realize the benefits of responsible self-care.