GPC2018 panel on patient empowerment in regulation 

Thursday, 12 April 2018

Margareth Ndomondo-Sigonda one of the speakers on the panel on Patient Empowerment in Regulation explains why improvement in medical products and pharmaceutical regulation is vital and how harmonization can be achieved.

When it comes to medical products and pharmaceuticals, each country is required to have a system that regulates those products, authorizes what can enter their market, and prevents substandard and falsified medicines from reaching healthcare facilities and dispensaries. This can be a lengthy, demanding process that requires considerable financial and human resources.

One solution could be continental harmonization — the streamlining of regulation systems across multiple countries. While Europe fostered this approach many years ago through the European Medicines Agency, Africa still lags behind. Margareth Ndomondo-Sigonda, head of health programs at the New Partnership for Africa's Development Agency, asserts that this needs to change. Although medicine regulatory harmonization has achieved success over the past decade or so, there is a need to sustain this momentum, and use lessons learned and best practices from proven initiatives as a precursor to establishing strong continental regulatory institutions.

“If you don't harmonize, if each country is doing things in their own way, the chances are that — because of the capacity limitations in those countries — you have a situation where products needed by people in that country may not be easily available because they are not allowed to be marketed,” she said.

Ndomondo-Sigonda explains that if a robust system for market authorization is not in place, new medicines cannot enter the market and people can be subjected to substandard products that could harm their health. The solution: pooling resources, speeding up the approval process, and getting people the care they need by harmonizing regulation and authorization systems across the African continent.

The panel on Patient empowerment will consist of the following experts in the field regulation: 

Andre Furia-Helms on behalf of the Food and Drug Administration which is responsible for protecting the public’s health by ensuring the safety, efficacy, and security of human drugs, helping to speed up innovations that make medical products more effective, safer, and more affordable as well as helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health in the United States of America.

Natalie Bere will be representing the  European Medicines Agency protects public and animal health in 28 EU Member States, as well as the countries of the European Economic Area, by ensuring that all medicines available on the EU market are safe, effective and of high quality.

Russel McGowan on behalf of the Health Care Consumers Association of the ACT an association that aims to provide a means for health care consumers to participate in local and national policy, planning and service decisions that affect their health.

Margareth Ndomondo-Sigonda on behalf of the African Union’s  New Partnership for Africa's Development (NEPAD) Agency a programme that  aims to establish and improve standards and requirements related to the regulation of — and access to — safe, high-quality medicines for the African population.

Janis Bernat speaking on behalf of the “Fight the Fakes” campaign which  aligns the actions of leading public health organizations, coordinating their efforts to speak up against fake medicines.  This campaign seeks to give a voice to those who have been personally impacted and to those working to put a stop to this public health threat.


For more information on patient empowerment in regulation, stay tuned to IAPO’s coverage of the 8thGlobal Patients Congress 24-26 May.