Newsletter
PHARMACEUTICAL AFFAIRS ACT AND FOOD HYGIENE CON-TROL ACT AMENDED
In the past, the media in Taiwan have often pub-lished advertisements for pharmaceutical prod-ucts, or even non-pharmaceutical products that exaggerated therapeutic effects. On 28 April 2006 the Legislative Yuan enacted amendments to the Pharmaceutical Affairs Act to increase the penalties applicable to the media that publish advertisements of pharmaceutical products with therapeutic effects that have not been approved by the regulatory authority.
In the future, a business not registered as a pharmaceuticals firm or a media organization, but publishes an unapproved advertisement making exaggerated claims as to the therapeutic effects of a pharmaceutical product can be fined from NT$200,000 to NT$5 million. If it con-tinues to publish such advertisement after being set a deadline to cease publication or correct the content, it can be fined NT$600,000 to NT$25 million, which is far higher than the maximum fine of NT$300,000 under the old Act.
The amendments also provide that if a non-pharmaceutical product is suspected of being harmful to human health, a media organization must cease transmission of advertisements for the product immediately upon being given a notice so to do by the regulatory authority, must retain data about the advertiser for a period of six months, and may not refuse to allow the regula-tory authority to inspect related data.
Since the Health Food Control Act first took ef-fect on 3 August 1999, there have been numerous proposals that the Act should be amended to in-troduce a dual system for product permits, and that related penalties should be increased. On 28 April 2006, the Legislative Yuan enacted amendments to the Act. The main content is as follows:
A "health food" is defined as a foodstuff pos-sessing health-caring benefits, and for which health-caring benefits are claimed. Health-caring benefits are defined as scien-tifically documented effects of improving health and reducing risk of disease that fall within categories announced by the Depart-ment of Health; such effects are distinct from therapeutic effects in the treatment of disease.
A two-track system is introduced for product permits: In addition to the existing case-by-case review system, a system based on specification standards is introduced, whereby a product can be approved if it com-plies with standards defined by the DOH. The product may then make claims consistent with the officially recognized effects. This measure is expected to result in an increased number of products being licensed as health foods.
Penalties for prohibited claims are increased: fines for noncompliant labeling and exagger-ated advertising claims are increased from NT$60,000 – NT$300,000 to NT$100,000 – NT$500,000, or NT$400,000 – NT$2 million if therapeutic effects are claimed. In serious cases, the health food license issued by the DOH may be revoked, and the business and factory licenses of the violator may be can-celled.
Media' liability is increased: the time period during which a media organization must retain data on advertisers is increased from two months to six months, and the deadline for ceasing publication of an advertisement after being notified that it is unlawful is reduced from three days to one day. Noncompliance is punishable by fines of NT$120,000 – NT$600,000, which is double the penalty under the old Act of NT$60,000–NT$300,000.