Improving regulatory environment and raising the role of self-care could relieve pressure on worldwide healthcare systems

Download PDF Copy

May 30 2016

A white paper, written by the Economist Intelligence Unit (EIU) and released today reports that greater regulatory harmonization and access to non-prescription medicines as a whole could improve the ability of patients to care for themselves and reduce needless costs to society, health systems, individuals and companies. Consumer Health: time for a regulatory re-think?, which is based on in-depth interviews with international experts from industry bodies, regulators, academia and patient groups, concludes that self-care and the topic of consumer health regulation is not receiving sufficient attention.

Within the report, RB calls on all stakeholders to proactively take action and urges the World Health Organization (WHO), whose role it is to provide global leadership in public health, to work in partnership with stakeholders to facilitate a change. A set of WHO Guiding Principles is recommended, to which governments, industry, regulatory bodies and healthcare system decision makers can adhere to encourage self-care and make self-care more accessible to more people.

One of the many challenges that regulation for non-prescription medicines faces is the fact that the framework for reviewing OTC products is actually based on prescription medicines. The specific role of self-care is not clearly defined or recognized by decision makers. For the full potential of self-care to be reached, a tailored system to regulate non-prescription medicines is required.

The report shows that although the OTC sector has benefitted to a degree from various harmonization initiatives centered on pharma as a whole, the range of regulatory issues and the way they interact make it difficult to foresee progress unless the OTC sector’s specific issues are addressed separately.

Zephanie Jordan, Vice President, Global Regulatory Affairs, RB said, “There is a clear and apparent need for a people-centered approach to OTC regulation. We believe it’s our responsibility to drive discussion on this topic and foster change. Until self-care is taken seriously at a national and international health and medicines policy level it will be difficult to break down many of the barriers to make self-care more accessible. We would like to see a system with the objective of designing the minimum necessary regulation to promote self-care while protecting people’s safety.”

The report includes industry voices on the next steps to addressing the barriers including:

Calling for governments to acknowledge and effectively build self-care into national health policy
Establishing a defined role for self-care that will provide a platform to drive the discussion on change
Agreeing to the objective of designing the minimum necessary regulation to promote self-care while protecting patient safety
Creating a specialized regulatory approach designed to encourage mutual recognition, help less developed regulatory systems to improve capacities, and genuinely encourage enhanced consumer empowerment

In addition to the economic benefits, self-care is what people want. With improved health literacy and support from pharmacists, self-care can result in healthier populations, stronger workforces and more sustainable health systems,”

“Governments need to do more to implement self-care policy and promote positive behavior change.”

said John Smith, CEO, Proprietary Association of Great Britain.

Non-prescription, or over-the-counter (OTC), medicines are an essential part of the most widespread element of healthcare provision: self-care. Patient empowerment and the self-care agenda has come into focus due to increasing and wide-ranging pressures on health systems around the world. The strain on health resources and budgets is unprecedented and is set to continue given the expanding and ageing population. The value of self-care and self-medication is realized by people managing common minor ailments themselves and as a result, valuable medical resources can be redirected to more serious illness.

The economic impact of improved access to consumer health has been demonstrated by numerous studies which have found that:

Minor ailments in primary care practice costs the UK NHS around £2bn (US$3.1bn) in 2006-07
One in five consultations with Primary Care Practitioners (PCPs) and hospital emergency departments could have been handled through self-care in UK¹
In US every dollar spent on OTC drugs led to health system savings of between six and seven dollars
The shift of care to self-medication in the enlarged European Union by 5% would exceed €16 billion in total annual savings

The RB report, written by the EIU highlights many of the challenges and barriers resulting from an inconsistent and fragmented policy and regulatory environment which hamper access to consumer health and OTC innovations. The EIU recommends major steps towards stronger international discussion, cooperation and understanding to facilitate change.

Source: Economist Intelligence Unit

References