Essentials for Success! – Join DIA China Medical Affairs and Medical Writing Training Now

Essentials for Success! – Join DIA China Medical Affairs and Medical Writing Training Now December 9-10, 2013 | Shanghai, China With the changes in local and global environments and requirements for compliance in the healthcare, more challenges are expected for the professionals working in the medical affairs and medical communication communities. The course, which is designed based on adult learning principles, evidence and rich experience, will provide highly interactive opportunities for participants to learn. The course will benefit professionals by providing knowledge, experience, and tools to better navigate ways through the challenges associated with communication and trusted relationships development with external and internal customers. Who Should Attend Medical Affairs Medical/Scientific Writing Clinical Research & Development Medical Communications/Information Professional Development Download the Program   Program Chairperson   Main Instructors   Min IRWIN, MD, PhD Vice President, Medicines Development, GlaxoSmithKline, China   Karen WOOLLEY, PhD CEO, ProScribe Medical Communications, China, Japan & Australia Professor, University of Queensland and University of the Sunshine Coast, Australia Julie MONK, PhD Medical Writer, ProScribe Medical Communications, China, Japan & Australia Upcoming Event DIA China Member Online Management Dear Member DIA China Member Management is now online. You can log in DIA China website at www.diachina.org to view and manage your data for receiving the latest international pharmaceutical information.

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by Narayan Ramachandran for Live Mint
For complete article, click here: http://www.livemint.com/Opinion/zqnV2T5dz0XaGITEmSHfqI/Patently-unfair.html

The story of the Supreme Court turning down Novartis’s patent petition for a new and improved Glivec is well known. Less known is that the decision, made on the basis of Section 3(d) of the Indian patent law, is really a technical ruling rejecting the new and improved idea. A patient sympathizer would say the improved notion was merely an attempt by the company to evergreen the drug by extending the patent regime and keeping out generics for longer. A patent sympathizer would say the improved version was truly a more efficacious drug; how is a company to innovate if it cannot protect its innovation? Precisely how a court of law was able to adjudicate on such a technical matter (reasonable experts may well differ) is not clear, but the ruling is binding.
 

The fight is really about the future. It is about how different the future of the pharmaceutical industry will be from its past. It is about the pricing of drugs. It is about how governments will go about balancing patent and patient in a world in which the gap between rich and poor is wide (both within a country and internationally). Could we have a different price for inner city Washington DC, Kenya and India from that in the developed markets? Should the full impact of that differential be borne by the pharmaceutical company or also by the chain of stakeholders—rich consumers, insurance companies and governments? 

India's Supreme Court Allows Continued Low-Cost Generics.

The New York Times (4/2, A1, Harris, Thomas, Subscription Publication) reports in a front-page story, "Production of the generic drugs in India, the world's biggest provider of cheap medicines, was ensured on Monday in a ruling by the Indian Supreme Court," meaning the populations of developing countries "will continue to have access to low-cost copycat versions of drugs for" HIV and cancer. The court ruled that a previous patent for Novartis' Gleevec prevented the company from taking out a new patent on the drug. According to the Times, "the debate over global drug pricing is one of the most contentious issues between developed countries and the developing world." Because the US allows companies to repatent a drug by altering its formula or changing its dosage, the country "pays the highest drug prices in the world." Now, "the United States government has become increasingly insistent in recent years that other countries adopt far more stringent patent protection rules, with the result that poorer patients often lose access to cheap generic copies of medicines when their governments undertake trade agreements with the United States."

        The Washington Post (4/1, Lakshmi) reports, "Many international drug companies have said that the Novartis trial was crucial to addressing the rapidly growing perception around the world that India's patent protection system for drugs is weak." Recently, "other Western pharmaceutical companies have been facing similar patent-related setbacks in India." While health activists and Indian drug companies argue "most Indians cannot afford expensive patented drugs," the ruling also "is a huge boost for India's $26 billion generic drug industry."

        The New York Times (4/1, Gottipati) reports in its "India Ink" blog, "The case represents a high-stakes showdown between defenders of intellectual property rights, who say generic versions stifle innovation by drug makers, and Indian drug companies and international aid groups, who warned that a ruling in favor of Novartis could have dried up the global supply of inexpensive medicines to treat AIDS, cancer and other diseases."

        The AP (4/2, George) reports, "Novartis called the ruling a 'setback for patients,' and said patent protection is crucial to fostering investment in research to develop new and better drugs. Ranjit Shahani, the vice chairman and managing director of Novartis India, said the ruling 'will hinder medical progress for diseases without effective treatment options.'"

        Another AP (4/1) story reports, "Major drugmakers such as Pfizer and Bayer AG on Monday declined to say what they might do regarding the ruling and other recent decisions by poor countries to let local drugmakers sell cheap generic versions for medicines that have monopolies under patents in Western countries. ... One thing is clear, though: Emerging markets are not the gold mine that optimistic pharmaceutical executives have been making them out to be."

        The Los Angeles Times (4/1, Alpert) reports, "Despite its objections to the ruling, Novartis said it was unlikely to challenge the court decision." Meanwhile, Tahir Amin, co-founder of the Initiative for Medicines, Access and Knowledge, "said the next battleground for generic drugs will be a Pacific free trade agreement under negotiation among a long list of countries, including the U.S., Canada, Mexico, Vietnam and Malaysia."

       
Also reporting this story are the Wall Street Journal (4/2, Subscription Publication), Bloomberg News (4/1, Von Schaper, Patnaik), Reuters (4/2), another Reuters (4/2), The Hill (4/2, Viebeck) "Healthwatch" blog, Time (4/1), NPR (4/1) "The Two Way" blog, Forbes (4/1), and BBC News (4/2).

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Book Now to Enjoy Insightful Sessions in May Dear Colleagues, Due to unavoidable circumstances we will be postponing the 6th Regulatory Conference in India. The conference will now be held on Thursday 23rd and Friday 24th May at the Courtyard Marriott in Ahmedabad, Gujarat. It is DIA’s constant endeavor to bring to you world class programs with renowned speakers. We hope you can join us at the conference in May. Seats are still available for the event. Please take a look at the conference program to find the sessions that interest you and register today. Best regards, DIA India Read More Download Program Register

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Don’t Miss the 5th DIA China Annual Meeting The Preliminary Program for the 5th DIA China 2013 Annual Meeting is now available and registration is open. Find the key themes and sessions at this year's event and register early! Register Now View the Preliminary Program PROGRAM CO-CHAIRPERSONS Lingshi TAN, PhD General Manager, Pfizer (China) R&D Co., Ltd. Vice President, Pfizer Worldwide Development Operations, China Yajun ZHAO Director-General, China Center for Pharmaceutical International Exchange(CCPIE), China PROGRAM VICE CHAIRPERSON Dayao ZHAO, MD, PhD Vice President, Janssen Pharmaceutical Research & Development Head of China Research & Development and Scientific Affairs ANNUAL MEETING THEME SNAPSHOT Chemistry, Manufacturing and Controls (CMC) /cGMP Clinical Research and Operations Data Management Drug Safety and Pharmacovigilance Regulatory Science Statistics The Pathway to Success for CROs and SMOs in China Vaccines and Biologics New Programs: SFDA Town Hall Meeting Regulatory and Drug Safety Joint Session: Balancing Risk and Benefit during NDA and Post Marketing Periods Botanical Drug Products in China and the United States Future Oncology Drug Development: Opportunities and Challenges Innovation on Medical Devices and Combinational Products Pharmacoepidemiology – Best Practices and Drug Safety Pharm/Tox Post Approval Studies Development of Novel Traditional Chinese Medicines (TCMs) PRECONFERENCE WORKSHOPS Maximize your learning while attending the 5th DIA China Annual Meeting! Pre-conference workshops include: Analysis of Data Patterns to Monitor and Assess Outcomes of Clinical Studies Drug Substance and Drug Products Stability Requirements and Practice in Early Phase Development Data Management for Oncology Trials Applying MedDRA with Clinical Safety and Pharmacovigilance Practices: Regulatory Perspective Global Clinical Trials - Principles and Case Studies LESS THAN TWO MONTHS LEFT TO SUBMIT YOUR RESEARCH Call for Abstracts Deadline: Monday, February 25 Call for Posters Deadline: Monday, March 25 Click here for information about submission of Abstracts/Posters. CHINA ANNUAL MEETING CONTACTS: China Office: dia@diachina.org XIE Fei: fei.xie@diachina.org HU Rui: rae.hu@diachina.org Tel: +86-10-6260-2240 Fax: +86-10-6260-2201

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