The purpose of drug regulatory institutions should be to safeguard the best interests of the patient and to drive patient centred healthcare worldwide.
Consequently, improving public awareness and providing information and education on the subjects that matter to patients must be the foundation of strong regulatory regimes, so that they’re on track to keep treatments that work available and to prevent disease. How far are we from this vision?
I was left pondering this for a workshop at the International Conference of Drug Regulatory Authorities (ICDRA Cape Town) called “Regulating medical devices: the involvement of stakeholders.” I spoke at a pre-ICDRA evening session “#patientsRwaiting: Why regulatory system strengthening matters” and led a talk during the workshop titled “What does the patient expect from regulators and industry in regulating medical devices?”
For many years, governments’ investment in healthcare has been regarded as a political choice, with healthcare services struggling for resources against other considerations and priorities. We need to change this attitude and instil the belief that healthcare is not a cost burden, but an investment. And patient engagement is fundamental to turning this investment into a success.
If we take the example of successful businesses, many today involve their target audience, namely consumers, with their decision making processes and plans. This partnership makes them effective in their strategy. Similarly, our approach to healthcare should be one where patients are not considered the beneficiaries, but the co-drivers of health, along with governments and other stakeholders. How do we ensure that this becomes the benchmark for how healthcare is delivered everywhere?
We need to first focus on awareness and education so that it’s possible to enlist and call upon patients, not just regulators and manufacturers, to co-own and drive the future of healthcare. Secondly, a robust and standardised legal framework is essential to unify and harmonise the work of the many drug and medical devices institutional bodies in each country (as well as other institutions that are mandated by law to oversee and regulate healthcare services, hospitals, and professionals). The African Medicines Regulatory Harmonisation (AMRH) programme is an example of a project that is making strides in this direction by working in partnership with other organisations. Finally, investment is key to facilitating collaboration between the parties.
If we are to harmonise all these institutional bodies and strengthen investment, more support should be dedicated to the National Medicines Regulatory Authorities (NMRAs) that are established by national governments to assess medicines and to exert effective market control. NMRAs are accountable to both the government and the public; their decision making processes with regards to the approval of and access to medicines should be transparent and clear.
One of the biggest challenges facing the healthcare landscape today is the diverse range of directives, regulations, standards, and procedures that govern the approval of medicines across countries and regions. Not only does this impact the availability and accessibility of medicines from country to country, but it also means that the quality and safety of medicines can vary too. The consequences for patients can be huge. For example, it can result in the same medicine varying in quality across a region depending on the country, and it increases the risk of fake medicines in a market. It can also result in potentially hazardous situations where patient information regarding administration can be difficult to understand.
Ultimately, inconsistency between healthcare systems can hamper equal and timely access to medicines and challenge the realisation of the patient’s right to health. The sharing of information with stakeholders is crucial for the success of this harmonisation process. And, since patients are one of the stakeholders, they should be involved by NMRAs in the assessment process and contribute to a better and more effective use of resources.
We have witnessed major changes in the role of patients in the past few decades. Twenty years ago patient groups were few and far between; today, many regulatory systems in different countries are evolving to include patient engagement in their policy and strategy.
For example, last year Cyprus passed a legislative proposal making patient involvement in policy making mandatory. And in 2018 the African Medicines Agency (AMA) will be launched to harmonise medicine regulation across the African continent. It will provide a platform for the coordination and strengthening of ongoing initiatives between member states.
No health system is sustainable without the engagement of patients and carers. The advantages to be gained from engaging patients are not simply for improving health, but also for reducing the costs of care.
Author’s note: Compiled from discussions at the 2016 pre-ICDRA (WHO International Conference of Drug Regulatory Authorities), Cape Town, South Africa, where I was a speaker at an IFPMA-IPASA event on “#patientsRwaiting: Why regulatory system strengthening matters.”
Kawaldip Sehmi is CEO of the International Alliance of Patients’ Organizations.
Competing interests: None declared.