BERLIN — A sustainable and strong medicines regulatory system at country level is paramount to any good health care system. It enables access to quality-assured medicines while also deterring substandard and falsified medical products from the market — a problem which exists in many countries.
In 2017, 1 in 10 medicines in low- and middle-income countries were found to be falsified or substandard, meaning that thousands of people were exposed to further health risks. Think antimalarials that don’t mitigate the risks of the deadly disease, or oxytocin that doesn’t function, leaving women to hemorrhage after childbirth.
“To me, a country’s success should not automatically be seen as a solution if you cannot maintain or sustain it.”— Dr. Souly Phanouvong, director of Asia programs, USP
According to USP — a global health organization improving lives through public standards and providing technical assistance to regulators and manufacturers to increase access to safe medical products — without access to quality-assured medicines and medical products, countries won’t be able to achieve universal health coverage.”
In today’s complex globalized supply chain, there are multiple points of potential failure. Even if a medicine is of high-quality when it leaves the factory — and this is not a given — there is the potential for degradation along the supply chain due to poor storage conditions so that by the time it reaches the patient, it may no longer be safe or high-quality,” said Dr. Souly Phanouvong, director of Asia programs at USP.
To dig deeper into this topic, USP released a paper named “Expanding Global Access to Essential Medicines: Investment Priorities for Sustainably Strengthening Medical Product Regulatory Systems.” In discussion with Devex, Phanouvong shared key recommendations from the paper on how countries can harmonize their regulations around medicines and medical products to ensure improved access to those that actually work.
The conversation below is edited for length and clarity.
Following the release of USP’s paper, what key recommendations do you have for expanding global access to essential, quality-assured medicines and products?
The message to the donor communities is that they should consider investing in regulatory capacity building as part of any program that they give funds to within developing countries — specifically those that do not have access to timely, quality, essential medicines.
To the governments, what I’d like to recommend based on this paper’s findings — as well as from my many years of experience working with countries to strengthen their regulatory function — is that they have to recognize that access to quality, essential medicines is critical. They really need to put this higher up the agenda, not only from a public health perspective but for the country’s sustainability, economic, and social development.
For the medicines regulatory authorities specifically, they should make sure that they have capacity and meet the requirements of being operational based on the World Health Organization’s global benchmark. Registration, postmarketing surveillance, licensing, and lab capacity building are the key functions that should be in place, at a minimum. For instance, without a strong registration function, which enables the review and acceptance of lifesaving medicines on the market, patients could be deprived of a critical medication. Take the treatment for multidrug-resistant tuberculosis; countries could wait many months or years while the product for treatment waits for regulatory approval.
To the pharmaceutical industry, they must understand and accept that quality has to be built into the product during its design and manufacturing using a systematic approach and control based on sound science and quality risk management. If they realize that they do not have the right infrastructure or know-how, they should not go in that direction. They’ll only compromise the quality and safety of a product.
To civil society and the academic community, I think they should advocate for more investments in regulatory system strengthening with recognition that countries need to safely and effectively procure their own medicines given the eventuality that they will graduate from donor support. Without this investment, a public health crisis or crises could be precipitated.
How can the global health community bolster efforts toward medicines regulation harmonization?
The importance of medicines regulation harmonization to the work of the global health community cannot be underestimated. Ultimately, it’s the idea of countries working together to assure the quality of medicines and medical products crossing borders. If a product is made in country A, then sent to country B, can the product still be presumed to be of the highest working quality once it reaches a patient?
Regulation harmonization could prevent such situations and ultimately saves lives. It is important to invest in supporting harmonization efforts leveraging existing vehicles such as New Partnership for Africa’s Development/African Medicines Regulatory Harmonization or Association of Southeast Asian Nations/Pharmaceutical Product Working Group to own and drive the work.
Where do investments need to be made to push progress forward in medicines regulation harmonization?
First, any investment should be assessed for its sustainable approach. This includes specifically human resource development. As soon as the project starts sustainability should be a component in that program or that project, otherwise it will be delayed.
“A country’s success should not automatically be seen as a solution if you cannot maintain or sustain it.”—
We learned a big lesson in Asia. Starting from 2003, the reduction of the falsified substandard medicines decreased over time from as high as 45 percent — depending on geographic area and the product — down to less than 5 percent within eight or nine years. Then the donor community would say, “Oh, things are done, so we should invest our resources somewhere else,” without properly building the sustainability in the government. They needed to put money into the human resource infrastructure to keep that program going.
To me, a country’s success should not automatically be seen as a solution if you cannot maintain or sustain it. It may lead to failure and then you have to start from scratch again.
What is your call to action for the global development community around this idea of improving access to quality-assured medicines?
To me, as an action-oriented type of individual, I always used the acronym of NATO: “No action, talk only.” I would like to make it very clear that we should avoid this and transform NATO into ANTO: “action, not talk only.”
I see very positive engagement on the part of the donors in the community at the international level and at the regional level, but this call to action on access to essential medicines using the risk-based approach in capacity building is something that everyone should take part in.
We’ve already got the first step done, let's move to the second and third step to make that happen, perhaps at the pilot phase at the country level, the regional level, and then, of course, scale up to the international level.
Any donor investing in procuring lifesaving medicines should also consider a long-term “exit strategy” to enable countries to sustain progress long after donors are gone. This means investing in strong regulatory systems to bring lifesaving medicines on the market and to ensure the medicines that are circulating in a country do the job intended.