SHANGHAI – A group of major European drug developers said Chinese patients are being denied innovative new medicines, according to press reports covering the most recent meeting of the pharmaceutical working group of the European Union Chamber of Commerce in China.

Drug makers that are part of the European chamber said during a recent meeting in Beijing that China’s goal of becoming an innovative society by 2020 is being jeopardized by long and unnecessary approval processes for clinical trials, plus difficulties in maintaining quality across the market.

The working group includes approximately 30 European pharmaceutical companies with operations in China; more than 20 have established factories that produce not just for China, but also for export throughout the region or even globally. The total investment by European pharmaceutical companies in China is about €700 million.

During the meeting, delegates said continued problems with current pharmaceutical regulation could create new barriers for Chinese patients seeking access to innovative new medicines, according to press reports.

The slow regulatory process for clinical trial applications in China creates challenges for drug makers. In China, it normally takes between nine and 12 months to obtain approval for a clinical trial, compared to only 60 days in Europe; hence, a sizable time lag between drug registration in China and Europe exists, the working group noted.

There is an array of major difficulties facing international drug firms that aim to conduct clinical trials in China, according to Ivy Teh, managing director of the Singapore-based healthcare consultancy Clearstate.

“It is a time-consuming process to apply for clinical trials of new drugs. The application process generally takes six to 12 months before a final approval is obtained and this is strictly supervised by the healthcare authority,” Teh told PharmAsia News. “As this application process may vary from international standards, it may confuse multinational companies that are not familiar with China’s regulations.”

“In addition, the trial period typically lasts for a long time for most drugs, except for those drugs under the expedited approval process,” said Teh. “The long trial period may result in multinational companies missing the best timing to launch new products into the market.”

The low number of registered clinical trial facilities in China, with all these facilities being level three hospitals, is a major difficulty, Teh noted.
“Up to 2009, there were only 236 clinical trial facilities registered in China to support the demand of clinical testing for innovative drugs,” Teh said. “Consequently, this increases the difficulty for drug manufacturers to find registered clinical trial organizations nearby their factories. This scarcity is even more prominent as the distribution of clinical trial facilities is fairly uneven across China.”

“For instance, nearly 30 percent of these organizations are centralized in only three metropolises: Beijing, Shanghai and Guangzhou,” she explained. “In addition, clinical trial organizations are only able to conduct specific types of trials approved by the State Food and Drug Administration and the Ministry of Health. In particular, Beijing, Shanghai and Guangzhou clinical trial facilities are able to conduct two to three times more categories of drugs testing compared to other cities in China.”

Thus, international drug firms with operations outside of tier one cities might be drastically limited in the choice of facilities to clinically test their innovative drugs. These firms might need to refer to clinical trial hospitals located in Beijing, Shanghai or Guangzhou for some of their new drugs, Teh added.
Government support for local drug manufacturers is another great barrier for international firms, according to Teh.

In many provinces in China, the government encourages and supports clinical trials of innovative drugs from local pharmaceutical companies rather than from multinational firms, she said. “This might include the faster new drug clinical trials application approval of local drug manufacturers by authorities.”
International drug firms are thus placed in a rather disadvantaged position in some regions in China.

The European Union Chamber of Commerce pharmaceutical working group said the failure to enforce the Ministry of Human Resource and Social Security’s stipulation in 1999 on updating the National Drug Reimbursement List at least once every two years is a further restriction on Chinese patients’ access to innovative medicines.

In China, only medicines that are included on this list are eligible for reimbursement under the national health scheme. At the provincial level, province-level health authorities establish their own list on the basis of the national list.

Last November’s update of the central list increased the number of Western drugs to which Chinese patients can gain access through the healthcare system; however, the last update before that was in 2004.

The E.U. has raised concerns about this issue with China’s Ministry of Commerce several times in the past, but has been rebuffed each time.

Due to the high cost of research and development of innovative drugs, along with numerous layers of supply chain intermediaries between the manufacturer and the patient, these medicines are typically priced at a premium when launched, which also limits the average Chinese patient’s ability to afford innovative drugs, according to Teh.

- Ying Huang (pharmasia@elsevier.com)

copyright © 2010 F-D-C
FDC Reports is the publisher of “The Pink Sheet”; “The Pink Sheet” DAILY; “The Gray Sheet”; “The Tan Sheet”; “The Rose Sheet”; Pharmaceutical Approvals Monthly; “The Gold Sheet”; “The Silver Sheet”; Health News Daily; PharmAsia News, an Elsevier company.

Industry leaders join to offer market access solutions for biopharmaceuticals, biotechnology, and medical devices across Asia-Pacific markets

Singapore (April 14, 2010) – Clearstate Pte. Ltd. and United BioSource Corporation (UBC) today announced a strategic partnership to provide global market access, pricing and reimbursement strategies for manufacturers of biopharmaceuticals, medical devices, and other medical technology.

The agreement reinforces Clearstate’s position as the premier source for accurate and actionable market intelligence across the Asia-Pacific region and builds upon UBC’s leadership in delivering global market access strategies for life science products. The alliance provides UBC and its clients with reliable access to the highest quality market access, pricing and reimbursement information.

“UBC offers many of the industry’s leading scientific and industry experts and a unique portfolio of capabilities to support the worldwide development and commercialization of biopharmaceuticals, medical devices, and other medical technology,” said Tej Deol M.D., Clearstate’s Managing Partner. “This, agreement underscores our desire to build collaborative strategic relationships with global firms capable of providing the highest quality health care advisory services. Our relationship with UBC demonstrates our shared commitment to provide clients with the most accurate and comprehensive market intelligence for markets in the Asia Pacific region,”

“We are extremely pleased to partner with Clearstate to offer comprehensive market access strategies throughout the Asia-Pacific region,” said Lisbet Coulton, Director of International Pricing and Reimbursement at UBC. “As life science companies expand their operations throughout the Asia-Pacific region, UBC and Clearstate are ideally positioned to support their products. Our clients have been delighted with the insight and expertise provided by Clearstate and we believe our partnership offers significant value for companies seeking effective market access solutions in this region.”

About Clearstate Pte. Ltd.
Founded in 2006 and headquartered in Singapore, Clearstate is a market intelligence firm committed to the Healthcare and Life Science domains specifically within the Asia Pacific region. We offer strategic advisory and customized primary research solutions to help medical devices, healthcare services, pharmaceutical and biotechnology firms understand their current and potential markets, and implement pragmatic and innovative strategies to ultimately tap into new growth opportunities within these opaque and challenging markets. For more information about Clearstate, visit its website at www.clearstate.com.

About United BioSource Corporation
United BioSource Corporation (UBC) is a global scientific and medical affairs organization that partners with life science companies to develop and commercialize biopharmaceuticals, medical devices, and other health care technologies. We help deliver authoritative, real-world evidence to characterize product effectiveness, address safety risk, and demonstrate value. UBC brings together recognized scientific and industry experts, research operations professionals, and new technologies to provide innovative solutions across the product lifecycle. The company is headquartered in Bethesda, Maryland, with offices in North and South America, Europe and Asia. For more information about UBC, visit www.unitedbiosource.com.

For more information please email us at:

info@clearstate.com
info@unitedbiosource.com

Singapore (March 1, 2009) – Clearstate Pte. Ltd. and Boston Healthcare announce the signing of an agreement to initiate what both parties anticipate to be an exciting and mutually beneficial productive long-term relationship.

This deal will help consolidate Clearstate’s position as the premier source for accurate and actionable life sciences market intelligence in the Asia Pacific region and enable Boston Healthcare reliable access to the highest quality information on pharmaceutical market access and pricing and reimbursement policies across Asia Pacific to complement their extensive North American and European product and service lines.

“The Boston Healthcare international network is an impressive group of established regional experts in health care pricing and reimbursement, and this agreement reflects our desire to continue to build collaborative relationships with progressive firms engaged in the provision of the highest quality services within the health care advisory space. The relationship also underscores our commitment to provide global clients with the highest quality comprehensive market intelligence as it pertains to the relatively opaque Asia Pacific markets,” said Tej Deol M.D., Managing Partner, Clearstate.

Adam Barak, Vice President of Boston Healthcare comments that, “For seven years we have been providing our clients with comprehensive services across the world in the areas of pricing, reimbursement, and market access for pharmaceuticals, medical devices, and diagnostics. In this time we have seen an increase in the requests from our clients for work in the Asia Pacific region. We are pleased to acknowledge that our clients have been delighted with the insight and expertise which Clearstate has provided and we welcome Clearstate into our international network to represent us in this important region and complementing our global service offering.”

About Clearstate Pte. Ltd.

Founded in 2006 and headquartered in Singapore, Clearstate, a niche health care consultancy, offers strategic advisory and intelligence services to help medical devices, health care services, and pharmaceutical and biotechnology firms understand their current and potential markets, implement pragmatic and innovative strategies to ultimately tap into new growth opportunities. Our approach to engagements is centred on thorough analysis of fact-based intelligence and seasoned understanding of markets, practical strategy recommendations and implementations. We also provide accurate, reliable and comprehensive intelligence on medical device usage and demand across Asia Pacific. Our Gateway series of market trackers are an in-depth analysis of historical, current, and future demand behaviors and preference trends amongst health care and commercial settings. The real benefit of our data extends beyond just providing market visibility; our comprehensive understanding of the medical device market in Asia from years of actual industry experience enables us to provide intelligence and advisory services that addresses the specific sales and marketing objectives of Life Sciences companies. For more information about Clearstate, visit its website at www.clearstate.com.

About Boston Healthcare

Boston Healthcare helps emerging and established companies gain competitive advantage in an increasingly complex health care marketplace. We provide reimbursement, business development, and market strategy services to biopharmaceutical, medical device, and diagnostic clients worldwide. Boston Healthcare supports the development of market access strategies and their ultimate implementation. We accomplish this globally through support from an international network of country-based experts. All of our network members have on the ground expertise in their respective countries in reimbursement, pricing, health economics, and health care systems. Together, we have completed over 150 projects in international pricing and reimbursement planning and implementation for innovative health care technologies.

Boston Healthcare’s unique approach, combining strategic consulting with a deep understanding of the business development and reimbursement environments, gives clients a real-world edge in assessing, creating, and capturing growth opportunities. For more information, visit www.bostonhealthcare.com

For more information please email us at:

info@clearstate.com

info@bostonhealthcare.com

Singapore (December 26, 2008) – Clearstate Pte. Ltd. and Medtech Insight announce the signing of adistribution and revenue sharing agreement to initiate what promises to be an exciting long term mutually productive relationship. This deal will help bring Clearstate into a position to sell its advisory and database products to a wider range of customers across the globe and gives Medtech Insight a reliable and committed partner to provide Asia Pacific market research reports to complement their extensive North American and European product lines.

Medtech Insight is known in the Life Sciences industry for their range of Market and Technology Reports in areas that include Cardiovascular Therapeutics and Diagnostics, Interventional Radiology and Vascular Procedures, Orthopedics and Musculoskeletal, Surgical Markets, Wound Management, and a wide range of other therapeutic and diagnostic markets. “We are very excited to work with Clearstate,” said Neil Smith, Director, Medical Device Reports with Medtech Insight. “Teaming up with Clearstate to provide Asia Pacific market research is an exciting development for our company and will enable us to provide the most comprehensive analyses of the devices, technologies, procedures, and companies shaping the global medical technology market.”

“Medtech Insight is an established well respected company within the Life Sciences intelligence space and this agreement reflects our desire to collaborate with companies that share our vision and underscores our commitment to provide Life Sciences clients with the highest quality comprehensive and actionable market intelligence especially as it pertains to the relatively opaque Asia Pacific markets”, said Tej Deol M.D. Managing Partner, Clearstate.

About Clearstate Pte. Ltd.

Founded in 2006 and headquartered in Singapore, Clearstate, a niche healthcare consultancy, offers strategic advisory and intelligence services to help medical devices, healthcare services, pharmaceutical and biotechnology firms understand their current and potential markets, implement pragmatic and innovative strategies to ultimately tap into new growth opportunities. Our approach to engagements is centred on thorough analysis of fact-based intelligence and seasoned understanding of markets, practical strategy recommendations and implementations.

We provide accurate, reliable and comprehensive intelligence on medical device usage and demand across Asia Pacific. We deliver actual and up-to-date placement, usage and consumption data for devices, equipment and consumables found in healthcare and commercial settings. For more information about Clearstate, visit its website at http://www.clearstate.com.

About Medtech Insight

Medtech Insight, a division of Elsevier Business Intelligence (formerly FDC-Windhover), provides the medical device and healthcare investment industries with consistent, comprehensive and meticulously researched market analyses that incorporate strategic vision and a thorough understanding of competing technologies. For more on the company’s products, services and investment and partnering events, please visit www.medtechinsight.com