2014年-普华永道全球_Asia-Pacific_Health_Industries_Newsletter_-_July_2014_16页_1mb

报告摘要

Asia-Pacific Health Industries Newsletter Summary (Issue 11, July 2014)

Core Content Overview

This issue of the Asia-Pacific Health Industries Newsletter provides an update on regulatory, market and strategic developments across the pharmaceutical, biotechnology, medical device, diagnostic and healthcare sectors in the Asia-Pacific region. The newsletter includes insights on compliance, pricing, M&A, digital health, big data and tax changes in key markets such as China, India, Korea, Australia and Hong Kong.

Main Topics and Key Information

Compliance: China

Nine Prohibitions to Strengthen Ethical Conduct in the Healthcare Industry:
- The Chinese government has introduced a new set of ethical guidelines targeting healthcare professionals (HCPs) and institutions.
- Prohibitions focus on preventing improper donations, travel and entertainment expenses, and the misuse of patient data.
- Provincial authorities are also enforcing compliance, such as requiring internal audits and signing ethical agreements with sales representatives.

Pricing: China

Removal of Highest Retail Price Caps for Selected Drugs:
- The National Development and Reform Council (NDRC) removed price caps on approximately 500 government-guided priced drugs.
- This shift suggests a move towards a more market-driven pricing system.
- Manufacturers can now set prices independently, but must not exceed daily allowable price ceilings (RMB3 for Western drugs and RMB5 for TCM).
- Domestic pharmaceutical companies may need to re-evaluate their pricing and market access strategies.

Digital Health: India

Challenges and Growth of Digital Health (mHealth):
- Digital health in India is currently limited to SMS-based communication among health workers and professionals.
- There is potential for smartphones to be used for remote diagnosis, similar to developed countries.
- Legal frameworks are needed to govern mHealth activities, including laws akin to HIPAA and HITECH Act in the US.
- PwC highlights the importance of regulatory changes for the growth of digital health in India.

M&A: Korea & India

Korea: Dong-A Pharmaceutical Acquires M.I. Tech Co., Ltd.:
- Dong-A Pharmaceutical acquired a 98.96% stake in M.I. Tech for KRW12bn.
- M.I. Tech specializes in non-vascular stents and exports 80% of its products to foreign countries, mostly in the EU.
- This acquisition is expected to strengthen Dong-A's medical device portfolio and competitiveness.
India: Sun-Ranbaxy Deal:
- Sun Pharmaceutical acquired Ranbaxy Laboratories for USD3.2bn from Daiichi Sankyo.
- This makes Sun Pharmaceutical the world's fifth-largest generic drug manufacturer and the largest in India.
- The deal includes a significant boost in market presence and access to Ranbaxy's drug pipeline and US OTC market.

Big Data: India

Availability of Nationwide Patient Records:
- The Indian government is pushing for the mandatory implementation of Electronic Medical Records (EMRs) in hospitals that accept government insurance schemes.
- The initiative aims to better understand disease patterns and manage healthcare delivery.
- Big data analytics will be essential in meeting these new regulatory demands.

Taxation: Australia, Hong Kong, China, Singapore

Australia: 2015 Federal Budget Changes:
- Corporate tax rate reduced from 30% to 28.5% for the 2015 income year.
- R&D tax offset reduced from 40% to 38.5% effective from 1 July 2014.
- A new 1.5% Paid Parental Leave (PPL) Levy is introduced for companies with taxable income over A$5 million.
- The PPL Levy effectively brings the overall tax burden back to 30%, negating the benefits of the lower corporate tax rate.
Hong Kong: New Companies Ordinance:
- The new Companies Ordinance (effective March 2014) allows for court-free amalgamations under certain conditions.
- This provides opportunities for streamlining corporate structures.
- Tax implications are still unclear, and companies are advised to seek advance rulings before proceeding.
China: M&A Activities and Taxation:
- The State Administration of Taxation (SAT) issued Public Notice 72, which provides new guidance for Special Tax Treatment (STT) in corporate restructuring.
- STT allows for tax deferral on gains from inter-group equity transfers, but lacks detailed implementation rules.
- Circular 14 encourages M&A and tax policy reforms, including relaxing CIT rules and improving land appreciation tax and value-added tax policies.
China: Opening up for Wholly Foreign Invested Medical Institutions (PFTZ):
- The Shanghai Pilot Free Trade Zone (PFTZ) allows foreign investment in medical institutions, no longer restricted to Hong Kong, Macau, and Taiwan.
- Precondition includes at least 5 years of direct experience in medical investment and management.
- No branches are allowed, and the application process involves the PFTZ Administration for Industry and Commerce (PFTZ AIC).
- Although the policy is a positive step, there are still challenges like lack of tax support, limited equipment quotas, and social insurance coverage.
Singapore: 2014 Budget Changes:
- Although not detailed, the newsletter mentions changes to the 2014 Budget affecting the healthcare sector.

PwC Insights

Compliance in China: Companies are reassessing their compliance programs in response to stricter regulations on HCP conduct and data privacy.
Pricing in China: The removal of price caps signals a move towards market-driven pricing, requiring companies to adjust their strategies.
Digital Health in India: Legal frameworks are crucial for the growth of mHealth, and PwC is supporting state governments in implementing health information systems.
M&A in China: Companies should monitor tax policy changes and prepare for potential impacts on their restructuring and M&A strategies.
Taxation in Australia: The reduction in corporate tax rate is partially offset by the new PPL Levy, affecting MNCs' tax credits.
Hong Kong: Court-free amalgamations offer opportunities, but tax clarity is still needed.