"HARMONIZATION BY DOING" PROGRAM BETWEEN THE US AND JAPAN
The US and Japan are currently working to expedite medical device approvals through the “Harmonization by Doing” (HBD) initiative. The HBD program was launched in December 2003, with its first meeting held in December 2005. A second meeting will take place in January 2007.

HBD was initially launched to focus on regulatory convergence between the FDA and Japan’s Ministry of Health, Labor and Welfare (MHLW) for cardiovascular-oriented medical device technology (specifically, drug-eluting stents). By developing common protocols for investigational clinical studies, HBD would utilize parallel development, application submission, and review of medical devices by both the FDA and the MHLW. By harmonizing clinical trial data so that it could be used in both the US and Japan, HBD would allow for shorter approval times. Though this initiative is currently limited to cardiovascular products, it could be expanded to include other fields such as orthopedics.

Establishing these guidelines would not only expedite medical device approvals, but also provide:

• more robust clinical trials
• improved clinical research infrastructure,
• better clinical trial data,
• better understanding of how the U.S. and Japanese experience can complement one another,
• and decreased time lag between U.S. and Japan product approval.

The FDA has also suggested that HBD could be applied not only to pre-market activities but also to postmarket clinical trials, and the collection of postmarket data and patient registries.

The HBD program currently holds shared meeting or “think tanks” which are open to the public to get feedback on the program. The next HBD think tank will take place on January 10-11, 2007 at Duke University in North Carolina.

NEW HEALTH INSURANCE PAYMENT SYSTEM IN TAIWAN
Taiwan ’s Bureau of National Health Insurance (BNHI) plans to change its payment system to a Diagnosis-Related Group (DRG) system in the next year. By establishing this DRG system, the BNHI hopes to decrease waste and improve hospital efficiency.

A DRG system means fixed payment, where the BNHI will fix the payment price for each disease requiring in-hospital care. Even if a hospital’s actual cost of treatment is less than the set price, the hospital could still receive the full payment from the Taiwanese government. BNHI hopes that with this new payment scheme, it can encourage hospitals to be more efficient and improve care to patients as the hospital keeps any extra money.

However, there are concerns that a DRG system may affect patients with severe conditions negatively as the cost for treatment can be very high. Those who are terminally ill or with chronic conditions may also suffer under this new payment system with price ceilings.

The BNHI has stated that the DRG system will not be applied for treatments for AIDS, rare diseases, cancer, hemophilia and mental illnesses. Children will be given preferential payments, and hospitals will receive an 8.9% bonus for taking in patients with more serious conditions.

The DRG system is to cover 182 diseases and conditions, including areas in dermatology, urology, renal, ENT, oral cavity, multiple traumatic injuries, subcutaneous tissue or breast. It is estimated that over 400,000 patients will be affected with this new payment system.

INDIA'S PROPOSAL FOR A MEDICAL DEVICE REGULATORY FRAMEWORK
India ’s Department of Science and Technology (DST) has recently prepared a draft legislation on a regulatory framework for medical devices. Currently, some medical devices are classified as drugs and are regulated by the Central Drugs Standard Control Organization. However, since many of the forms and regulations are tailored towards drugs, doing device applications is often difficult and impractical.

Because there is no mechanism or regulation specifically for ALL medical devices, this new framework would provide the initial steps in establishing a separate section for medical device registration in India. For example, validation would be required before any medical device is certified for use in India.

The Srichitra Tirunal Institute of Medical Sciences in Kerala worked on this regulatory framework for two years to help the DST. The Minister of Science and Technology, Kapil Sibal, said they will submit the draft legislation to the Ministry of Health soon, and hopes that the legislation will be approved by Parliament in a couple of sessions.

Because India depends heavily on imported medical devices, the DST hopes that this new regulatory framework would encourage international companies to increase exports and also to manufacture in India. India has some high quality manufacturers and cheaper labor costs which encourage manufacturing there. Medical software is another area India should excel in.

WHO'S TASKFORCE AGAINST COUNTERFEIT MEDICINES
The World Health Organization (WHO) and various international partners came together in Germany November 2006 to develop a task force focused on preventing the global spread of counterfeit medicines. The International Medical Products Anti-Counterfeiting Taskforce, or IMPACT would cover legal, technological, communications and regulatory issues to address the concerns of the growing trend of counterfeit drugs.

The WHO estimates that over 30% of medicines in some areas of South East Asia are counterfeit. In wealthier countries, the WHO estimates that almost 50% of medicines sold online are counterfeit.

For many countries, the laws and regulations of counterfeiting medicines are no more different than the laws and penalties of counterfeiting luxury items. With IMPACT, the WHO hopes to amend this issue in many countries and also provide a basis for regulations on the whole for counterfeit medicines.

Thailand , Malaysia and China are a few of the countries which have had various issues with counterfeit drugs. In fact, the Pharmaceutical Services Division under the Ministry of Health in Malaysia has confiscated over US $12 million worth of unregistered drugs in the last five years. China investigated over 300,000 reports of counterfeit drugs last year worth about US $6.3 million and closed 530 factories.

Some Asian countries have already begun to address counterfeiting issues with IMPACT’s support. Indonesia has begun campaigns to educate the public and Vietnam is working to coordinate between customs, regulatory and police to improve surveillance on counterfeit medicines.

WHO and IMPACT will present principles to help countries set up model legislations. They are also looking into technologies from mobile telephone companies to provide a system of authenticating drugs and confirming their authenticity. IMPACT is also looking into DNA-based technologies and nanotechnology. By the end of 2007, IMPACT hopes to have all 193 WHO Member States working together to curb the growing numbers of counterfeit medical products.