2017-10-09

Medical Law News

Taiwan's Executive Yuan on 21 September 2017 passed amendments to the Pharmaceutical Affairs Act, which now awaits review by Taiwan's Legislative Yuan. These amendments specifically define "new drugs", "generic drugs", and "biologics".

Per the draft amendment, "new drugs" refer to drugs of new compositions, new therapeutic compounds, and or new methods of administration as verified and recognized by the relevant authority, or drugs having different forms, dosages, or amounts per unit; "generic drugs" are any drugs that have the same compositions, therapeutic compounds, forms, dosages, or amounts per unit as drugs already verified and recognized by the relevant authority; and "biologics" are all drugs made from biological ingredients.

Taiwan's Executive Yuan plans to cancel the current regulations that require certain biologics, such as vaccines, to be batch-sealed, in the hope of shortening the time required to put these products on the market.

Meanwhile, to offer a different method for resolving medical disputes, Taiwan's Ministry of Health and Welfare has proposed a first draft of the Medical Dispute Resolution Act.

In this draft, all medical disputes will be required to be mediated by an independent third party set at the local Health Bureau, which consists of legal and medical experts, before such disputes can be brought to the Courts. Such mediations would be conducted in 90 days, and may be extended for another 90 days if needed. Compared to litigating medical disputes, which can take as long as 3.5 years at the first trial instance, mediation offers a faster and less expensive means to resolve medical disputes.

Finally, Taiwan's Ministry of Health and Welfare plans to establish an independent institute, consisting of legal and medical experts, to offer medical-legal reports to the relevant authorities in these cases. Parties may learn the initial analysis in these medical-legal reports and decide then whether they wish to bring such cases to the Court (after mediation).
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