Navigating Emerging Markets: Southeast Asia - A unique demographic and payer mix make ASEAN an increasingly attractive region. - BioPharm International

ADVERTISEMENT

Navigating Emerging Markets: Southeast Asia
A unique demographic and payer mix make ASEAN an increasingly attractive region.


BioPharm International
Volume 23, Issue 6, pp. 42-46

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.

IN-REGION CONSIDERATIONS

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.


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

Pfizer to Acquire Vaccines from Baxter
July 30, 2014
GSK Submits EU Regulatory Filing for Malaria Vaccine Candidate
July 29, 2014
Bristol-Myers Squibb and Ono Pharmaceutical Collaborate on Immunotherapies
July 28, 2014
FDA Accepts First Biosimilar Filing
July 24, 2014
Compounding Pharmacy Issues Recall, But Challenges FDA Decision
July 22, 2014
Author Guidelines
Source: BioPharm International,
Click here