The pharma industry is expanding rapidly across Asia, but there are concerns about whether drug safety measures are keeping pace. The strength of pharmacovigilance (PV) systems in a country is an indication of the advancement of its pharmaceutical regulations.

PV is crucial for public health protection, and all regulated markets have strong PV systems. At a global level, the World Health Organization plays a key role in promoting and supporting PV systems in developing countries and encourages them to develop strong PV systems and become members of the WHO Programme for International Drug Monitoring (IDM). WHO defines PV as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.” In simple words, PV is the process of monitoring the safety of blood products as well as pharmaceutical products, including medicines, devices, vaccines, and biologicals.

In ASEAN, the PV systems are diverse, and the lack of harmonization is a key challenge for companies and other stakeholders in the pharma industry, which is growing rapidly.

A $2 Trillion Market

Today, pharma companies are focusing on ASEAN countries to plan their next stage of growth, mainly because of its largely untapped economic potential and ongoing economic growth. The Asian pharmaceutical market is expected to grow at an annual growth rate of 9.1 percent from 2016-2021, and markets in Southeast Asia are among those that will drive this trend.

Moreover, the establishment of the ASEAN Economic Community (AEC) in 2015 was a major milestone toward regional economic integration and is likely to boost the pharma industry, among others. The AEC offers opportunities in the form of a market worth $2.6 trillion and 639 million people, making it the world’s third largest market in terms of consumer base and the fifth largest economy in terms of GDP.

However, with AEC, there were expectations of a single registration process for new pharmaceutical products to get approvals in all 10 countries. It was also expected that there would be uniform regulations, including uniform PV regulations.

Unfortunately, this is not the case, and there are significant differences in PV regulations among ASEAN countries.

The PV Landscape in Asia

Of the 10 ASEAN countries, nine have a national policy or legal framework for implementing PV systems and are members of the WHO Programme for IDM. PV has yet to start in Myanmar, which is not a member of IDM. As per regulatory authority websites, seven countries (excluding Brunei Darussalam, Laos and Myanmar) seem to have clear PV regulations. In eight countries (barring Laos and Myanmar) it is mandatory that companies holding licenses for pharmaceutical products regularly report about their side effects to authorities. However, these reporting requirements differ across economies, too.

Exhibit: Summary of Key Activities

1. Compulsory reporting as per regulation 2. Risk management: the process of identifying and minimizing risks (side effects) associated with a drug 3. Signal management: early identification and management of risks associated with a drug 4. MAH: Marketing authorization holder, license holder 5. HCP: Healthcare professionals such as doctors, nurses, pharmacists

Challenges for PV in ASEAN

There’s a lack of clear communication from regulatory authorities, and gaps exist in written regulations and actual enforcement. Moreover, ASEAN countries are at different levels of economic growth, and all the regulatory authorities may not be equipped sufficiently to provide technical inputs for PV. They are also faced with challenges such as the scarcity or quality of labor and technical resources.

Furthermore, most ASEAN countries have their own systems of traditional medicine, which are not covered under PV and which make it difficult to evaluate drug-drug interactions. There is also a lack of awareness among health care professionals regarding the reporting of side effects, and the importance of complete and good quality safety monitoring remains a major challenge.

Pharma is expanding rapidly in ASEAN, but drug safety systems are still in the early development phase.

While MNCs that are expanding in ASEAN countries may already have the technical know-how for PV, domestic companies that are aspiring for growth must develop adequate PV systems. MNCs that are expanding in the region with the help of local marketing partners and distributors may face an additional challenge of training them in order to create awareness among them for developing capabilities to receive reports of side effects and promptly transmit them to MNC partners.

A Single Regulatory Body

To overcome these challenges, collective efforts are required from all stakeholders of PV. Preferably, AEC should consider developing a single regulatory body, such as the European Medicines Agency, by including the regulators of respective countries to have uniform pharmaceutical regulations across ASEAN. Clear guidelines and regulations regarding PV requirements will help in assuring compliance and safety monitoring. This can be achieved by collaborating with WHO along with agencies from regulated markets such as the U.S., Japan and the EU.

The problem of underreporting side effects by health care professionals and the poor quality of these reports can be addressed by increasing sensitization among health care professionals regarding the importance of PV. This is an area where the pharma sector and regulatory authorities can also collaborate, as pharma companies have the resources to interact with health care professionals.

The Need for Harmonization

PV systems in ASEAN countries are in the early development phase. While basic elements of the PV system seem to be in place for most of the member states, they need to be more clear, unambiguous and stringent. There’s a lack of harmonization of PV regulations among ASEAN countries. The implementation of PV regulations and poor allocation of resources for PV remain a challenge in most countries.

Despite the barriers in ASEAN PV systems, the national PV centers are putting efforts into training and information exchange. Collaborative efforts by all stakeholders to implement regulations and to create awareness among health care professionals regarding the importance of PV should help in the further evolution of the system.