STRICTER DRUG PRICES IN VIETNAM
Earlier this spring, Vietnam’s Ministry of Health conducted drug price audits with recent reports of price hikes. Visiting local pharmacies, representative offices of pharmaceutical firms and drug wholesalers, the Ministry of Health found 13 pharmaceutical companies increasing prices without appropriate government approval. Seven of the 13 were foreign companies, and the Ministry of Health has ordered all of them to reduce drug prices back to their December 2006 prices.

For price changes, the importer and product registration owner needs to notify the Drug Administration of Vietnam (DAV) and provide appropriate information such as import costs, product costs and taxes. The DAV will impose penalty fees for any unauthorized price increases. They also plan to conduct audits to ensure prices are adjusted accordingly.

Previously, pharmaceutical companies did not need to wait for price approval before putting their products on sale. In addition, some companies violated regulations by not listing prices or registering their prices with the government. The DAV has ordered that price increases must be made public. There has also been discussion of publishing a list of approved drug prices.

Vietnam’s Department of Pharmaceutical Management plans to reorganize price listings so that prices chosen cannot be higher than those in countries with similar health and economic conditions as Vietnam. Several pharmaceutical products will be affected, including antibiotics, anti-inflammatories, and pain relievers.

Due to price increases and markups through intermediaries, the Ministry of Health also plans to reorganize pharmaceutical sales and distribution. The Ministry plans to issue requirements on GDP (Good Distribution Practices), GPP (Good Pharmacy Practices), and GSP (Good Storage Practices). Non-compliant companies will have their pharmaceutical product trading licenses revoked. In addition, the Department of Pharmaceutical Management also plans to carry out unannounced inspections on pharmaceutical retailers.

INDIA DRAFTS LEGISLATION FOR MEDICAL DEVICES
The Central Government in India has recently drafted legislation to ensure quality control of vital life-saving medical devices such as endoscopes and pacemakers. Drafted by the Sree Chitra Tirunal Institute for Medical Sciences and Technology, the draft has been forwarded to the Ministry of Health and Family Welfare.

Some devices are regulated by the Drug Controller General of India. However, there is no regulatory body establishing and enforcing standards on medical devices. The bill proposes establishing regulatory guidelines to test and certify medical devices introduced into India. Foreign imported devices may also be required to be certified based on these regulatory guidelines.

Though India has already passed legislation this past March on devices such as cardiac stents, catheters, bone cements, and other sterile medical devices, the proposed bill would affect all medical devices.

JAPAN TO INTRODUCE “COMPASSIONATE USE” DRUG PATHWAY
The MHLW has decided to establish a special exception to allow the use of non-approved drugs for patients suffering from serious illnesses and having no possible alternatives for treatment. Currently, individual import of medical treatments is allowed in certain cases, but this new pathway would allow for importation via drug companies. The MHLW expects to establish this pathway in a few years and hopes to reduce importing hassles on patients.

Japan is using the “compassionate use” designation utilized in the US and the EU as a reference to establish which drugs would fall into this category and determining how expenses are allocated.

According to the MHLW, the new system would take into account the following factors when making their decision:

• If clinical trials are currently being conducted in Japan or have already been completed in Japan;
• If clinical trials are currently being conducted in the US or EU or have already been completed in the US or EU;
• And if the product has been approved in the US or EU.

The MHLW plans to include drugs such as anticancer agents delayed in product approval to drugs whose clinical trials have been postponed due to insufficient funding.

Once a drug is elected for this compassionate use pathway, it can be imported into Japan without being approved.

ASEAN MEETING ON MEDICAL DEVICES
The Medical Device Product Working Group of the ASEAN Consultative Committee for Standards and Quality held a meeting from July 30 to August 2, 2007 to discus various topics and strategies to increase harmonization of medical device regulations across the ASEAN countries. This was the 6th meeting so far. Objectives included improving medical equipment management through a post-marketing alert system to the Common Submission Dossier Template.

The ASEAN member countries agreed to establish a regulatory infrastructure to promote the access and use of medical technology. In addition, the meeting also discussed future areas for cooperation among the ASEAN countries, such as health insurance issues and healthcare providers.

The ASEAN countries consist of Brunei, Cambodia, Indonesia, Malaysia, Myanmar, Laos, the Philippines, Singapore, Thailand, and Vietnam.

CRACKDOWN ON COUNTERFEIT DRUGS IN THAILAND
Recent reports on counterfeit drugs in Thailand have prompted several government agencies, including the Intellectual Property Department, to investigate and crack down on fake drugs. The Food and Drug Administration (FDA) in Thailand said that over 30 sellers of fake drugs were arrested and over 300,000 products seized earlier this year. Last year, there were over 280 cases and seizure of almost 75,000 products.

The Intellectual Property Department is looking into trademark violations in addition to setting up checkpoints with border patrol. The police will also crack down on importers of fake drugs to stem the flow of counterfeit products.

Many of the discovered fake drugs were imported and sold freely on various night markets. These imitations ranged from copies of Viagra to painkillers and expensive medicines for heart disease and high cholesterol.

The FDA in Thailand is currently investigating if any registered firms have been involved in counterfeit drug production.