The pandemic triggered a behavioral shift within society, bringing about greater self-care to prevent illness and maintain good health. With greater access to health information than ever before, people are increasingly taking more accountability for their health and well-being. Simultaneously, the consumer health care product market has evolved, with products now being sold in an increasingly wide range of channels and points of sale, from pharmacies and groceries to e-pharmacies and online marketplaces, driven by industry innovation and diversification.
At the beginning of the pandemic, practically overnight, flexible regulations were introduced and enabled new, innovative processes to help people adjust to the constraints of lockdown. Digital platforms appeared everywhere to facilitate ‘contactless’ transactions. The growth of e-pharmacies flourished as people of all ages quickly adapted and embraced the evolving digital landscape. Prior to 2020, many markets either did not allow, or severely restricted, online sales of nonprescription or over-the-counter medicines. But during the pandemic, health authorities found themselves removing these barriers to allow the broader population to self-manage their health and well-being, while propelling pharmacists to the frontline of health.
This helped reduce the spread of infection, but also saved time and made life more convenient for those who either didn’t live near a pharmacy or had physical problems getting to one, especially under the constraint of a prolonged lockdown environment. For health authorities around the globe, it helped to ensure the rest of the population remained healthy as they heroically battled serious COVID-related illnesses.
Our post-pandemic world has accelerated digital ubiquity and fast adoption by people of all ages and across the world.
The new normal of our post-pandemic world has accelerated digital ubiquity and fast adoption by people of all ages and across the world. It has also highlighted the necessity of individuals to take greater accountability for their health — from regular hand washing and mask wearing to managing their mental wellness and self-managing minor and acute conditions — in order to stay healthy, protect loved ones, and remain productive. We forget sometimes that most of the world is under-resourced and access to self-care is a lifeline, especially to those who earn a daily wage. The inability to work due to a minor ailment, whether it is a migraine, allergy, body pain, or diarrhea, could mean not eating for the day. We are at a tipping point where this pandemic has prompted more proactive behavior change toward individual health management. In line with this, we need our governments and regulatory authorities to support an evolving environment that enables and empowers individuals to better self-care — safely and appropriately.
One way forward is regulation through reliance that aims to foster a more efficient approach to regulation, improving and expediting access to quality-assured, effective and safe medical products. Regulatory reliance, where regulatory authority in one jurisdiction uses evaluations performed by another regulatory authority in making decisions, is promoted by the World Health Organization (WHO), the Pan American Health Organization (PAHO) and the European Medicines Agency as a mechanism for better management of resources while strengthening regulatory systems.
What’s important to note is that ‘reliance’ does not represent a less stringent form of regulation, an outsourcing of regulatory mandates, or even a compromise to independence. On the contrary, for us in the consumer health care industry, the decision to ‘regulate through reliance’ should be the hallmark of a modern and efficient regulatory authority — streamlining regulatory submission, enhancing global supply systems, and accelerating approvals.[1] The EU Voluntary Harmonization Procedure is a perfect example of the positive effects of regulatory ‘reliance’ for both health industry and the patient, allowing the “harmonized authorisation by competent authorities of clinical trials in two or more EU member states after submission of a single application file (VHP)”.[2]
For this, we need a flexible and responsive regulatory approach. One that can adapt to rapid innovation, shifts in the practices of health care professionals, and ultimately, ensure industry and regulators can work together for the benefit of people and the planet.
Today, while regulatory ‘reliance’ looks at both prescription medicines and nonprescription products (over-the-counter medicines), there is a need to tailor and facilitate this further for over-the-counter medicines as these products have already demonstrated their safety and efficacy. Doing so will have a major impact on facilitating pathway approvals to bring products and innovation faster to consumers; lead to an increase in consumer confidence in the quality of these medicines; and bring significant cost savings to industry and health authorities alike. Ultimately, this translates to accessible health, enabling everyday good health and supporting productivity for everyone.
For this, we need a flexible and responsive regulatory approach. One that can adapt to rapid innovation, shifts in the practices of health care professionals, and ultimately, ensure industry and regulators can work together for the benefit of people and the planet.
Real-world data from consumers: how, when, where, and how often they use products, is a rich source of information.
One such area of collaboration that can lead to advances in self-care is in the gathering of real-world evidence (the clinical evidence regarding the use and potential benefits or risks of a medicinal product derived from analysis of real-world data) which has the potential to modernize our over-the-counter regulatory framework. Real-world data from consumers: how, when, where, and how often they use products, is a rich source of information. By working together with health authorities to secure greater acceptance and acknowledgment of Real World Data & Evidence (RWD/RWE), we can take product life-cycle management to a whole new level, facilitating new product innovation, supporting new claims for a new or expanded use of an existing product to a wider population, and eliciting confidence to enable Rx to over-the-counter switches. This will require solutions to improve data sources and alleviate the hurdles in using RWD/RWE for over-the-counters while always securing people’s privacy.
Sustainability is also a key regulatory consideration when it comes to doing the best for people and the planet. E-labelling is one great opportunity to do this. We unlock the digitalization potential of information (that is, QR codes, videos, infographics) facilitating inclusivity and fast access to trustworthy and accurate product information, while reducing the use of paper widely.
And of course, regulations are safeguards to protect the public from unauthorized and counterfeit medicines on rogue websites. In the U.S., the industry self-regulates with a voluntary verification scheme. In the European Union, an EU logo verifies the trustworthiness of an online store. And in Mexico, Brazil and Australia, online stores need to register with a regulatory authority.[3]
There are many great initiatives ongoing fueled by the pandemic impact. And never more so is collaboration between industry and government more critical with this health care evolution, to co-build a future that empowers consumers to safely place their health and well-being in their own hands. The benefit of this empowerment and giving people 24/7, 365 days a year access to products and associated health care information is clear. Recent research by the Global Self-Care Federation has shown that self-care brings significant benefits, such as improved quality of life, increased productivity, huge cost savings to economies and health care systems, and a significant reduction on physician workload.[4] On top of this, its latest findings show that people with strong health literacy skills enjoy better health and well-being, while those with weaker skills tend to have poorer health.[5]
These benefits are predicted to increase in the future. Moreover, integrating self-care in public health policy and programming supports the sustainability of health care systems. But for this to become a systematic reality, we need a conducive regulatory environment that encourages and facilitates people to take more responsibility for their own health. Such regulations should be about health outcomes, not on rules, with policymakers needing to consider what enforcement aims to achieve.[6]
The old adage ‘health is wealth’ couldn’t be more appropriate today. When you entrust people to take accountability for their health and give them the tools and capabilities to better self-care, you are giving them a gift every single day — of wellness, of productivity, of fulfilment, and in some cases, even survival.
[1] International Federation of Pharmaceutical Manufacturers & Associations. https://www.ifpma.org/wp-content/uploads/2019/06/IFPMA-Position-Paper-Regulatory-Reliance.pdf
[2] European Medicines Agency, Clinical Trials Regulation. Accessed on 17 July 2022 https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-regulation
[3] Regulation of e-Commerce of Non-prescription Medicines https://www.selfcarefederation.org/resources/regulation-e-commerce-non-prescription-medicines Last accessed July 2022
[4] The Global Social and Economic Value of Self-Care 2022 Report. https://www.selfcarefederation.org/ecosoc-report. May, 2022
[5] Global Self Care Federation. Health and Self-Care Literacy Report 2022. https://www.selfcarefederation.org/resources/self-care-literacy-policy-paper
[6] AESGP Annual Meeting.: Can Regulation Be A Catalyst For Innovation? https://hbw.pharmaintelligence.informa.com/RS152611/AESGP-Annual-Meeting-Day-2-Part-2-Can-Regulation-Be-A-Catalyst-For-Innovation June, 2022
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