China’s Stricter Supervision of Medical Product Advertisements
China ’s State Food and Drug Administration (SFDA) plans to set up a system recording companies’ advertising drugs, medical devices, and health foods, to better monitor and assess individual company performance. The new regulations will take effect on January 1, 2008.

In the new system, companies will be classified as “creditable,” “discreditable,” or “seriously discreditable” based on their compliance with medical advertisement regulations. Companies who have complied with advertising regulations over the past year will be classified as “creditable,” while those who have committed violations will be “discreditable.” The classification "seriously discreditable" will be applied to companies with more than five violations.”

Recently, China has upped its supervision of illegal advertisements of medical products, identifying over 30,000 illegal ads just this year. In addition, the SFDA has cited 16 ads which overstated the benefits and efficacy of their product without scientific support. Many of the 30,000 illegal ads exaggerated the benefits of their products. Serious offenders under the current regulations may lose their advertising licenses.

The SFDA is urging the country's local food and drug oversight bodies to increase their supervision of advertisements. Previously, local food and drug administrations have worked with the SFDA in developing an online ad approval system. In addition, all approved ads are posted on the SFDA’s website for public reference.

Changing Landscape for Multinationals in Philippine Pharmaceutical Market
In October 2007, the Philippine Senate approved the Quality Affordable Medicine Act. More commonly known as the “Cheap Medicines Bill,” this Act contains many initiatives aimed at lowering drug prices in the Philippines and giving more support to the country's generic drug manufacturers. The Act also includes a number of new regulations regarding intellectual property and drug development.

An important change the Act makes to the patent process is a new restriction of patentable inventions. It explicitly states that the discovery of a new form or new property of a known substance will not merit a patent unless it results in greater efficacy of that substance. This parallels Section 3(d) of India's patent law, which Novartis recently failed to overturn in the Indian courts. Overall, the patent law changes may make “new use” patents harder to obtain and allow generic versions of off-patent medicines to enter the market sooner.

The Act also introduces "parallel importation" to allow generic drugs to enter the Philippine market more quickly. This process allows for importation of patented products from abroad, without the consent of the patent-holder. In other words, a company could import a patented drug marketed in another country and undercut the patent-holder's price on the Philippine market..

Other plans to help generics include “Early Working,” which allows generic companies to develop and test generic versions of a drug in expectation of its patent expiring. In addition, third parties would be able to access data on patented drugs to facilitate the future registration of generic versions. Early Working would make it easier for generic producers to start production and sale of a generic drug immediately after the patent expires.

To increase the use of generics, the Act also requires doctors to only write generic names of drugs on medical prescriptions. In addition, drug outlets would be required to inform all buyers of all other drug products with the same generic name.

The Act also discusses recent Department of Health recommendations on strengthening the Bureau of Food and Drugs (BFAD). These recommendations include expanding the BFAD's research and regulatory capacity, making its administrative structure more flexible, and imposing mandatory disclosure of drug prices sold in foreign markets.

Asian Harmonization Working Party Updates
The Asian Harmonization Working Party (AHWP) had its last meeting on October 26 and 27 in Chengdu, China, where it discussed schedules and plans for the Common Submission Dossier Template (CSDT), Post-market Alert Systems (PMAS) and other tasks. For CSDT and PMAS, the AHWP is considering following GHTF documents such as STED and NCAR (National Competent Authority Report). AHWP hopes to implement the CSDT and PMAS starting in 2008. For more information on CSDT and PMAS, please refer to Vol. 6 Issue 9 and Vol. 7 Issue 4 of the Asia Medical eNewsletter here.

In addition to CSDT and PMAS, the AHWP also plans to establish working groups on harmonizing Quality Management Systems, Quality System Audits, Clinical Evidence Requirements, and Capacity Building/Regulatory Training. The chairs for these workings groups (except for Capacity Building) have not yet been determined.

During the meeting, Malaysia presented a comparative study on medical device regulations in Asian economies along with its findings and recommendations. One recommendation was to adopt GHTF definition and risk-based classification of medical devices. Of the 14 countries studied (including China, Hong Kong, Malaysia, Singapore, and others), 8 had adopted the GHTF definition of medical devices, but only 4 had adopted GHTF risk-based classifications. Another recommendation was for AHWP to consider region-wide nomenclature for medical devices.

Other recommendations included building a common reporting format for adverse events and recalls as well as a comprehensive database to monitor and analyze these events. The ASEAN PMAS currently in discussion would play a key role in the creation of such a database. Malaysia also presented recommendations for capacity-building to ensure that member economies have the resources to properly implement these international standards.

Many of the AWHP's working groups and initiatives are currently in review stage only. Their actual implementation is expected to start in 2008-2009.

Changes in Japan’s Medical Device Reimbursement
Japan 's government is planning to reevaluate its current reimbursement system and make appropriate cuts to reduce national medical spending. The main regulatory body responsible for deliberating reimbursement prices is the Central Social Insurance Medical Council (Chuikyo) . In the current system, every two years, Chuikyo compares the weighted average of medical devices' reimbursement price to their foreign average price (the price in countries as in the US, UK, Germany, and France). If the current reimbursements are more than twice the foreign average price, Chuikyo then reduces their reimbursement level.

Chuikoyo's areas of reevaluation include examining the appropriateness of the chosen foreign reference countries as well as improving reimbursement for innovative products. At present, innovative products can receive reimbursement bonuses. However, the system defines "innovation" vaguely, and Chuikyo is considering clearer definitions. For example, products could be classified as innovative for having less invasive mechanisms, reduced infection risks, or improved operability.

Budgetary constraints are constantly pushing Chuikyo and the Ministry of Health, Labor, and Welfare (MHLW) to reconsider national reimbursement prices. Since the budget for the upcoming fiscal year must be submitted to the Diet for approval, Chuikyo and MHLW’s reimbursement cuts will depend on budget levels.