Special Section: Latin America
two hands, one with a medical symbol and the other with a scale
Report from the 10th Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH)
Cammilla Gomes

uring the pandemic, regulators have seen the importance of their interactions with the health authorities in their jurisdictions to foster better communication channels that reach beyond their traditional stakeholders and meet the needs of the entire patient population. Knowing what to say has always been important. The pandemic highlighted the importance of knowing when, where, and how to say it.

One of the critical lessons that regulators and other healthcare stakeholders have learned from the global COVID-19 experience is the importance of trust:

  • Greater transparency into and proper communication of regulatory activities allow the public to trust regulators and industry at the global level.
  • Post-market activities are increasingly important to maintain trust in pre-market regulatory flexibilities.
  • All regulators should adopt at all times the strategy of reliance and work sharing, trusting in reliable organizations to avoid duplication of work.

This article highlights these and related discussions from the 10th Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH), organized and presented by the Pan American Health Organization (PAHO).

Evolution of Regulatory Systems in the Past Decade

During an open discussion between regulators and industry representatives about the trajectory of regulation in the Americas from 2010 to 2020, the PAHO Secretariat provided an overview of the main changes in the network’s operational model in response to the need for more agility in PANDRH’s technical work. These changes led to the adoption of new statutes focused on further promoting regulatory convergence, statutes which were expanded to include medical devices under their mandate, in areas aligned to the priorities set by network members.

This overview also summarized the main findings of the report Regulatory System Strengthening in the Americas: Lessons Learned from the National Regulatory Authorities of Regional Reference, published in April 2021, such as:

  • Establishing virtual communication channels to expedite submissions of digital documents
  • Expanding use of teleconsulting and telemedicine into clinical research and patient care
  • Expanding use of flexible evaluation and approval mechanisms such as compassionate use or emergency use authorizations.

(Listen to this Global Forum interview with PAHO Assistant Director Jarbas Barbosa to overview the main messages and other recommendations in this report.)

The regulatory scenario in the region has changed for the better during the past decade due to the strengthening of its regulatory systems. Recommendations from PAHO Resolution CD50.R9 (Strengthening national regulatory authorities for medicines and biologicals) have influenced this improvement, especially in being better prepared to respond to regulatory-related aspects of the current public health emergency. But it is also clear that this influence has not been equally shared across the region, and room for improvement remains.

Elements of the historical progression in promoting regulatory convergence and cooperation in the Americas remain relevant for building stronger regulatory foundations today; for example, the leading role played by the National Regulatory Authorities of Regional Reference, and continuing opportunities for regulators in the region to further engage with regional and international collaboration, and adopt internationally recognized technical guidelines and standards.

Regulatory Challenges and Responses to the Pandemic

FDA has issued guidance that illustrates the relevance of new and more flexible regulatory approaches in the approval of medical devices, as well as enhanced post-market activities, in response to COVID-19, while simultaneously stressing the need for increased communication with the public and engagement with the private sector.

This guidance served as the starting point for a panel discussion among a diverse range of experts from organizations including the World Health Organization, and moderated by representatives of the Bill and Melinda Gates Foundation, which focused on a strong regulatory system as the foundation to build a quality healthcare system, and the strategic challenges regulators face during the pandemic, such as:

  • The need to stay scientifically robust despite public pressure to cut corners
  • Understanding their community’s tolerance of risk, and developing new ways to evaluate benefit-risk for emergency use of products
  • Embracing more flexibility in procedures, which might mean creating new and more accelerated regulatory pathways for emergencies
  • Developing proper communication strategies that ensure the regulator as a trusted party for all stakeholders, even if the regulator must communicate uncertainties
  • Adopting reliance strategies on reference authorities to support greater efficiency.

Critical success factors for adequately meeting these challenges include:

  • Global (not nationalistic or individualistic “go it alone”) perspectives, resulting in cooperation among regulators through information sharing, work sharing, or reliance
  • Flexible and convergent regulatory approaches, especially more pre-market regulatory flexibility and providing more resources for post-market activities
  • Close collaboration between regulators, industry, and international organizations such as PAHO and WHO.

Post-COVID Regulatory Systems Agenda

Regulatory authorities in the Americas have also debated exploratory measures for achieving more equitable healthcare systems–to ensure that products which are demonstrated to meet quality, safety, and efficacy standards are delivered to the population in any country, regardless of the maturity of its regulatory authority.

In a conversation moderated by a representative of the World Bank, who connected the regulatory aspects of this discussion to concepts of global economic and social development, regulatory panelists reflected on what regulators might have done differently now that the impact of COVID-19 has been fully unveiled.

Their primary conclusion was that regulatory authorities must do a much better job of envisioning and positioning themselves as part of their respective national healthcare systems. This includes creating new and better communication channels that reach beyond their traditional regulatory stakeholders into other clinical research and/or clinical care communities and tailoring certain messages for their intended audience: knowing not only what is important to communicate, but when and how to communicate it.

The pandemic also highlighted how much the (current) low levels of convergence between local regulations and internationally accepted standards continue to negatively impact timely access to lifesaving products; this has not only been true for new products (COVID-19 diagnostics, vaccines, therapies) but also for traditional products with supply chains disrupted by this emergency.

This context has made the need for early engagement and global cooperation among regulators even more evident, and the collaborative International Coalition of Medicines Regulatory Authorities (ICMRA) has emerged as one key platform for strategic alignment and coordination in the Americas’ regulatory response to COVID-19. In the future, ICMRA might support creating alliances that unite regulators and industry in mechanisms to share data, deepen reliance, and avoid duplication of effort. Any regulatory activity, not only during health emergencies, can greatly benefit from increased and periodic sponsor-regulator interaction.

It is also important for governments to establish mechanisms that ensure greater technical autonomy in regulatory decisions and allow regulators to deliver greater efficiencies without jeopardizing the quality, safety, or efficacy of the products distributed locally. These government stakeholders must understand not only the role of the regulatory authority but the roles of scientists, developers, and manufacturers in their respective jurisdictions. Regulators have also learned the need to better communicate the data and rationale for product approvals in the public domain and have reached consensus that building a more public relations approach to health regulation will be beneficial in preparing for future health emergencies, as it builds trust and minimizes suspicion (for example, toward imported products).

Another vision for the future is to identify alternatives that can increase local production capacity and minimize the risk of total dependance upon imported ingredients and finished products. However, experience also shows that these local production strategies must maintain high regulatory standards and recognize that quality comes with a price. Polling the capacity of different countries within the same region can effectively leverage existing resources and maintain competitive prices for these products.

About the Conference

With participation of all regulators across the Americas, the PANDRH Network was created by PAHO in 1999 to support convergence in the region’s pharmaceutical regulation processes. In December 2021, PAHO organized and presented the virtual 10th PANDRH Conference to share lessons learned from the pandemic and prepare for upcoming post-COVID-19 regulatory challenges in the Americas. This conference provides an open forum for discussion of common regulatory topics and provides the network with guidelines and general terms for developing internal projects.