2015年-普华永道全球_Asia-Pacific_Health_Industries_Newsletter_-_August_2015_16页_1mb

报告摘要

Asia-Pacific Health Industries Newsletter Summary (Issue 14, August 2015)

Core Content Overview

This newsletter provides an update on recent developments in the pharmaceutical, biotechnology, medical device, diagnostic and healthcare sectors across the Asia-Pacific region. It includes insights on market trends, regulatory changes, M&A activity, and tax developments, with a focus on South East Asia, Japan, Australia, the Philippines, India, and Taiwan.

Main Sections and Key Points

Special Report – Healthcare in Asia

South East Asia: A new era in healthcare is emerging, driven by technological advances, empowered consumers, and the aging population. Patients are becoming more active consumers, demanding personalized and integrated health services. Companies must adapt to this shift by improving transparency, efficiency, and community engagement.
Japan: The country is facing significant healthcare cost pressures due to its aging population. The government is promoting Community Based Integrated Care Systems to reduce hospital bed shortages and encourage care transitions. Additionally, Health Technology Assessment (HTA) is set to be introduced in 2016, requiring pharmaceutical companies to submit cost-effectiveness data. There is also a push to increase generic drug usage to 80% by 2020.

Compliance

Australia: The Medicines Australia Code of Conduct (Edition 18) mandates transparency reporting, requiring member companies to disclose payments and transfers of value to healthcare professionals. The first data collection period began on 1 October 2015. Companies must ensure accurate data collection and validation with healthcare professionals.

M&A Trends in the Philippines

Pharmaceutical Industry: The Philippines is a growing M&A market, with major players like Robinsons Retail Holdings, Dairy Farm International, and Ayala Group acquiring companies to expand their reach and market presence. The industry is expected to grow at a 5.1% CAGR over the next five years.
Healthcare Industry (Hospitals): The country's hospital system is under pressure due to high patient demand and limited infrastructure. Major players such as MPIC, Ayala, and Chandler Corporation are actively involved in hospital acquisitions. The government plans to invest US$44 billion in health facility construction and aims for future privatisation.

Regulatory Developments

India: The Central Drugs Standard Control Organization has introduced new clinical trial regulations, including:
- Rule 122DAB: Compensation procedures for trial subjects.
- Rule 122DAC: Conditions for clinical trial conduct and inspection.
- Rule 122DD: Guidelines for Ethics Committee registration.
- Mandatory audio-visual recording of informed consent.
- The government is considering e-commerce regulations, particularly for online pharmacies, to prevent misuse and ensure proper drug use and safety.
Taiwan: The Long-term Care Services Act was passed in May 2015, aiming to address the aging population. The law establishes a comprehensive care system covering home, community, and institutional care. It also introduces a Long-Term Care Services Development Fund (NT$12 billion) and plans for a long-term care insurance system by 2018, which could help fund services and attract private investment.

Tax Developments

Australia: The ATO has revised its Advance Pricing Agreement (APA) process with a new practice statement, PS LA 2015/4, emphasizing early engagement and collateral tax issues. The new process aims to improve timeliness and reduce red tape. Taxpayers must prepare detailed information and build good relationships with ATO stakeholders to ensure smooth APA implementation.
Singapore: The Inland Revenue Authority of Singapore (IRAS) has updated its Transfer Pricing Guidelines, focusing on consolidating and clarifying the arm's length principle. These updates aim to streamline the process and ensure compliance with international standards.

Key Information and Insights

The healthcare industry in the Asia-Pacific is evolving rapidly due to demographic changes, technological innovation, and regulatory reforms.
Japan is focusing on cost control and efficiency through HTA, generic drug expansion, and community-based care systems.
Australia is enhancing transparency in pharmaceutical marketing and tax compliance with new APA procedures.
The Philippines is experiencing significant M&A activity in both pharma and healthcare sectors, driven by market growth and government initiatives.
India is addressing clinical trial regulations and e-commerce challenges, with a growing online medicine market.
Taiwan is introducing long-term care reforms to manage the aging population, including new laws and funding mechanisms.

PwC Observations and Recommendations

Japan: Pharmaceutical companies must rethink their sales and marketing strategies to align with regional care systems and HTA requirements.
Australia: Companies should automate transparency reporting and prepare for the rigorous APA process by mapping systems, training teams, and ensuring data accuracy.
Philippines: M&A activity is expected to continue, with major players expanding their portfolios. Companies should consider strategic partnerships and market entry opportunities.
India: A strong e-commerce regulatory framework is essential to ensure safe and effective online medicine sales.
Taiwan: The new long-term care insurance system could provide a stable funding source and encourage private sector involvement.

Contact for Further Discussion

John Cannings, OAM – Pharmaceutical & Life Sciences Leader, PwC East Cluster (AsiaPac)
David McKeering – Southeast Asia Insights
Shunsuke Horii – Japan Insights
Daniella Dickson – Australia Insights
Che M. Javier / Cheryl R. Dineros – Philippines Insights
Sujay Shetty – India Insights
Lily Wong / Damian Gilhawley – Taiwan Insights
Lyndon James – Australia Tax Insights