2016年-普华永道全球_Asia-Pacific_Health_Industries_Newsletter_-_April_2016_18页_1mb

Asia-Pacific Health Industries Newsletter - Issue 16 Summary

Core Content Overview

This issue of the Asia-Pacific Health Industries Newsletter provides updates and analysis across several key areas: Health and Safety, Tax, Accounting, Regulatory, Pricing, and Healthcare. It highlights developments in the pharmaceutical, biotechnology, medical device, diagnostic, and healthcare sectors across New Zealand, Singapore, Japan, China, and Australia, with a special focus on Taiwan.

Main Topics and Key Information

1. Health and Safety in New Zealand

• Integrated Health and Safety (IHS) Programs: The new Health and Safety at Work Bill in New Zealand is prompting organizations to reassess their readiness to protect their workforce from workplace risks.
• Aging Workforce: New Zealand has the second-highest employment rate for 55-64 year olds in the OECD. Older workers are more likely to suffer from chronic conditions and have multiple health risks.
• Health and Productivity: Research shows that organizations that manage the health of their workforce achieve better financial performance. However, many organizations still focus only on health protection, not health promotion.
• PwC Observations: To implement IHS effectively, organizations need to understand the underlying health needs of their employees and align programs with these needs. The focus should be on both health promotion and health protection.

2. Tax Updates in Asia-Pacific (BEPS Initiatives)

• Global BEPS Focus: The OECD's Base Erosion and Profit Shifting (BEPS) project is influencing tax policies in the region.
• Singapore:
  • Transfer Pricing Guidelines (2016): IRAS introduced stricter timelines for APA (Advance Pricing Agreement) processes and clarified that the cost plus method may include additional costs not actually incurred.
  • Compliance and Documentation: New requirements for Master File, CbC Report, and Local File for MNEs with significant revenue or intangible transactions.
• Japan:
  • 2016 Tax Reform: Introduced revised TP documentation requirements based on BEPS Action 13. MNEs with over JPY 100 billion in revenue must prepare and file Master File and CbC Report.
  • Local File: Required for companies with over JPY5 billion in related-party transactions or JPY300 million in intangible transactions.
• China:
  • SAT Focus: Emphasized the need to analyze contributions to intangible assets and ensure proper compensation by foreign related parties.
  • Future Actions: Expected changes include revising domestic tax laws, localizing BEPS, and improving international tax administration through IT.

3. Accounting Changes in Australia

• New Financial Reporting Requirements: Due to the Tax Laws Amendment (Combating Multinational Tax Avoidance) Bill 2015, multinational companies must now lodge general purpose financial reports (GPFS) with the ATO.
• SGEs (Significant Global Entities): Defined as entities or groups with consolidated global income of $1 billion or more.
• Reporting Changes:
  • SGEs not currently lodging GPFS with ASIC must now do so with the ATO.
  • Subsidiaries of foreign groups may be required to lodge GPFS if the parent company is an SGE.
  • The new requirements apply to financial years starting from 1 July 2016.
• PwC Insight: The legislation introduces uncertainty, and it is important to align with Australian accounting standards and consult legal and accounting advisors.

4. Regulatory Developments in Taiwan

• TFDA Accelerates Drug Approval: The Taiwan Food and Drugs Administration (TFDA) has streamlined the drug approval process, reducing the average time from 300-400 days to 171 days for priority-reviewed drugs.
• 2015 Drug Approvals: A record 170 new drugs were approved, a 30% increase from the previous year.
• Breakdown of Approvals:
  • 49 NCEs (New Chemical Entities)
  • 44 Biopharmaceuticals
  • Therapeutic Categories: Cancer (13%), Hepatitis C, HIV, rare diseases, vaccines, etc.
• PwC Observations: The TFDA's efforts to simplify and speed up the approval process are yielding results, with a rising number of approvals over the past five years.

5. Pricing Developments in Australia and Taiwan

• Australia - PBS Reforms:
  • Increased the number of annual PBS price changes from 3 to 5 times.
  • Introduced a one-off 5% statutory price reduction for all F1 formulary medicines after 5 years of listing.
  • Removed originator brands from price disclosure calculations after 3 years on F2 formulary.
  • Applied price disclosure reductions for single-ingredient medicines to related combination items.
  • Frozen indexation for the Community Service Order (CSO) during the agreement period.
  • Removed certain OTC medicines from the PBS.
• Taiwan - Drug Price Pressures:
  • Continued pressure on drug prices due to regulatory and market reforms.
  • The TFDA's efforts to increase approvals are expected to help reduce time to market, but pricing pressures remain a challenge.

6. Healthcare Outlook in Malaysia

• Growing Interest in Healthcare and Wellness: Malaysia is attracting investors and developers due to its growing healthcare market.
• Market Demand: There is an increasing focus on health and wellness as a sector with high potential for investment and growth.

Key Takeaways

• Health and Safety Integration: Organizations should move from a narrow focus on health protection to a more integrated approach that includes health promotion.
• BEPS Impact: Tax authorities are tightening transfer pricing regulations across the region, with significant implications for multinational pharmaceutical companies.
• Financial Reporting: Australia's new GPFS requirements are reshaping the reporting landscape for SGEs, emphasizing the need for alignment with accounting standards.
• Regulatory Efficiency: Taiwan's TFDA reforms are improving the drug approval process, which is a positive development for the pharmaceutical industry.
• Pricing Pressures: Both Australia and Taiwan are facing increased pricing pressures, which require strategic responses from companies.

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