“Medicine is the most powerful tool without question and universal health coverage is not being realized. Question is what breaches this tool and the people?” Prof. Roderick P. Salenga, Associate Member of NRCP Pharmaceutical Sciences discussed during the Expert Class Episode 12: Pharmaceutical Systems Strengthening and Access to Medicines: From "New Normal" and into the “New Future” last November 24, 2021, via Zoom.

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To start, he provided a flashback last December 31, 2019, where WHO’s Country Office in the People’s Republic of China picked up a media statement by the Wuhan Municipal Health Commission from their website on cases of ‘viral pneumonia’ in Wuhan from unknown cause. Comparing the situation last 2019 to present, “we are now in a better situation due to a handful of repurposed therapeutics which have been approved to treat COVID-19” Prof Salenga said. A total of 7,370,902,499 vaccine doses have also been administered, he added.

Fight against Covid-19

 

All over the world the communities showed their appreciation to different health care workers in essential frontline workers. According to Prof Salenga, health workers contributed a lot during the pandemic. Another important factor in the fight against Covid 19 is the existence of Robust Regulatory System. According to Prof. Salenga, effective regulatory systems are an essential component of health systems strengthening because these systems are able to contribute to better public health outcomes now more than ever. It is important to have access to lifesaving commodities and that would include not just medicines but also diagnostics and lifesaving vaccines.

Pharmaceutical System Strengthening (PSP)

Pharmaceutical system strengthening advances the access to medicines, especially in the context of the New Normal and New Future. “I'm hoping that we will be able to move forward with lessons learned from the current time so we can go forward to a better future” Dr. Salenga said. PSP is the process of identifying and implementing strategies and actions that achieve coordinated and sustainable improvements in the critical components of a pharmaceutical system to make it more responsive and resilient and to enhance its performance for achieving better health outcomes.

An improved PSP, regulation or effective regulation, is a critical enabler. In public health, it is a way to balance Market Control and Access and Innovation. Effective and Efficient Regulatory System play an important role during the new normal in two levels, namely in ensuring continued supply of existing critical medicines, such as those needed for severely ill patients with COVID-19, and for streamlined review and approval of new innovative medicines (including vaccines).

Opportunities and lessons learned amidst Pandemic

 

“We should take advantage of the lessons learned during the Pandemic” Prof Salenga said. The following are the lessons that should be taken as opportunities:

1. Extraordinary opportunity to deepen public understanding of safety, efficacy, and quality of products, including the processes that guarantee these

2. Exceptional chance to test existing systems, which prompted legislation/ policy/process updates (e.g., EUA, CSP, etc.), upgrade and integration of reporting platforms, and continuous review of guidelines, etc. 

3. Testing and scale-up of new ways of working

4. Enhanced collaboration between stakeholders and set-up of multi-expertise/sectoral bodies that accelerated processes, facilitated discussion, and supported timely decision-making; and

5. Understanding the role of regulatory authorities in handling too much information circulating, including false or misleading information in digital and physical environments that can cause confusion and risk-taking behaviors that can harm health.

Advice for the “New Nomal”

“Can the innovation, creativity, and speed applied during this ongoing pandemic be applied to other chronic, life-threatening, and rare diseases and to make drug development more efficient?” Prof Salenga asked. Accordingly, continue to explore and expand collaborations that could anticipate and leverage the regulatory changes:

1. Maximized clinical trial capacity, avoiding use of the same patients, and utilizing trial networks

2. Harmonized regulatory processes and mutual reliance to avoid duplication

3. Clinical evaluations via joint reviews or shared working models

4. Use of artificial intelligence, combined with human support and input, to advance regulatory review and post marketing surveillance processes, and improve adaptive clinical trial designs, real-world data methodologies, and use of biomarkers

Before he ended his lecture, he reminded the participants, “Recognizing that the virus will be with us for a long time, governments should also use this opportunity to invest in health systems, which can benefit all populations beyond COVID-19, as well as prepare for future public health emergencies.”

The lecture was followed by a reaction from the Expert, Dr. Isidro C. Sia, NRCP Regular  Member and executive director of the Integrative Medicine for Alternative Healthcare Systems (INAM) Philippines. According to him, Covid-19 is rampant, however, there are existing illnesses that should not be set aside such as Tuberculosis, Diabetes, Hypertension, among others. He also provided a recommendation for the access to medicine. There should be geographical data for clearer understanding. He also pointed out that aside from drug regulatory and the Food and Drug Administration (FDA), there is also the Health Technology Assessment Council (HTAC) of the Department of Health, formed under the Universal Health Care bill. HTAC is responsible for the cost effectiveness and access to medicine not only for Covid but for other diseases. Dr. Sia likewise highlighted the role of the public in balancing the access to medicine and quality.

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Prof. Salenga, Dr. Arollado, and Dr. Sia during the Q&A

The reaction of Dr. Sia was immediately followed by Q&A, moderated by Dr. Erna C. Arollado, Chair of NRCP Pharmaceutical Division. Prof. Salenga, together with Dr. Sia answered the questions raised by the participants such as effects of different brands of medicine/vaccines available to the public, improved regulatory system for the future, and more.

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Dr. Marieta Bañez-Sumagaysay, NRCP Executive Director and some of the participants of Expert Class Episode 11

In her closing remarks, NRCP Executive Director Dr. Marieta Bañez-Sumagaysay highlighted the issues on medical needs, health care facility, and access to medicine, especially to those who are vulnerable. She hopes that these will be given immediate national attention even after the Covid-19.

The online class had a total of 340 (177 females, 163 males) virtual enrollees including NRCP members, DOST agencies, students and teachers from different schools and universities, academe, DepEd, and media partners.