KEY REGULATORY CONSIDERATIONS
In terms of regulation, the ASEAN countries are becoming more synchronized in the regulatory sphere. The ASEAN Leaders have
resolved to form the ASEAN Economic Community (AEC) by 2015. The goal of the AEC is to establish ASEAN as a single market
and production base. Tariffs will be eliminated and other barriers between the countries will be phased out. Work on harmonizing
standards began in 1997, with pharmaceuticals, medical devices, and health supplements earmarked as priorities. Specifically,
ASEAN leaders have agreed to mutual recognition of inspections of medicinal-products manufacturers, including post-market
assessments. ASEAN has required the filing of an ASEAN Common Technology Dossier (ACTD) as the only regulatory filing required
for pharmaceutical companies to gain approval of their drugs in the 10-member ASEAN states starting in 2012. In general, this
standardization should reduce complexity for manufacturers interested in expanding into this region. Harmonization of standards
will help member countries to lower costs and increase the quality and availability of medicines in the region. It also formulates
rules for importing medicines to ensure quality drugs for the region. Recalls or product alerts in one country will be applicable
for all the member nations.
Pharmacovigilance (PV) in Asia is evolving, as the region becomes one of the largest players in the pharmaceutical market.
With increased numbers of clinical trials occurring in China, India, and the ASEAN region, the importance of managing adverse
drug events/adverse drug reactions (ADEs/ADRs) is gaining recognition. There are a number of challenges that manufacturers
will face with regard to developing a PV plan in ASEAN. These challenges include cultural variation in medical practice (Western
vs. traditional), lack of PV expertise, lack of human and financial resources in regional regulatory agencies, few robust
PV regulations, hesitation on the part of healthcare professionals to report adverse data, drug counterfeiting, and variable
quality in drug manufacturing.
Some ASEAN countries have reasonably structured PV systems. In Singapore, for example, the Vigilance Branch of Health Sciences
Authority employs a number of post-marketing risk assessment approaches to ensure the continued safe use of medical products.
These include mandatory reporting from pharmaceutical manufacturers, spontaneous reporting from health professionals, literature
reviews, and the exchange of regulatory information with other national drug regulatory bodies.
Many regulators in Southeast Asia are in the process of revising their existing regulations. There is also an ongoing collaboration
across the region regarding harmonization and enhancement of drug safety as part of ASEAN.
Other healthcare access considerations include country-specific items like the government's role in overall health spending.
Singapore, for example, has rejected the idea of a generous welfare system, but does fund free medical care at government
hospitals for the needy, and has created a universal health system characterized by medical savings accounts. While this system
is supported by subsidies, no healthcare services in Singapore are provided to patients free of charge; the out-of-pocket
expenses act as a deterrent from seeking out unnecessary services. Just less than half the hospitals in Singapore are government
run and tend to be less expensive for patients than their private equivalents.
Other countries in the region such as Thailand have funded largely government-run programs to achieve near-universal health
coverage for years, and other countries (e.g., Vietnam) are looking to employ some of the same tactics. Understanding the
payer mix and the challenges facing each of these payers will be crucial to understanding the market opportunities in each
of these markets.
In contrast, many of Indonesia's more than 250 million residents find even minimal healthcare inaccessible. Access to a physician
or other healthcare professionals across Indonesia's 6000 inhabited islands varies greatly. While larger cities generally
offer a range of medical services, in remote areas such as the province of Papua, it can take days to reach medical care.