The petitioner Máo Fēn- huì is a supervising physician of an Obstetrics and Gynecology Clinic in Taipei. Department of Health, Taipei City Government found the petitioner dispensed drugs to the patient in the original case without any of the exceptional conditions, “in the remote areas where practicing pharmaceutical personnel are not available as announced by the central or municipal competent health authorities” or “in the case of urgent need of medical treatment services” under Article 102, Paragraph 2 of the Pharmaceutical Affairs Act, which provides “after two years of the implementation of the National Health Insurance, the provision of the preceding Paragraph (note: i.e. the permission for a physician to dispense drugs based on his/her own prescriptions) shall be enforceable only in the remote areas where practicing pharmaceutical personnel are not available as announced by the central or municipal competent health authorities or in the case of urgent need of medical treatment services.”( hereinafter “Disputed Provision I”). Therefore, the Department of Health, Taipei City Government fined the petitioner NTD30,000 under Article 92, Paragraph 1 of the Pharmaceutical Affairs Act for non- compliance with the regulation that “the aforesaid dispensation of drugs shall be performed by a pharmacist.” under Article 37, Paragraph 2 of the Pharmaceutical Affairs Act. The petitioner disagreed with the decision and filed an objection for a review, which was rejected by the Department of Health, Taipei City Government. The petitioner then initiated an administrative appeal and an administrative litigation, which were ruled against her one after another and eventually rejected by the Taipei High Administrative Court order 103-Chien-Shang-Tze No. 105 (2014) (hereinafter “the final and binding judgment”).
Petitioner asserted that Disputed Provision I applied in the final and binding judgment has an issue of conflict with Articles 15 and 23 of the Constitution. In addition, both Article 50 of the Pharmaceutical Affairs Act Enforcement Rules, which provides that “’urgent need of medical treatment services’, as used in Article 102, Paragraph 2 of the Act, refers to circumstances in which a physician at a medical care institution, due to urgent need for medical care measures, must immediately use a drug.” (hereinafter “Disputed Provision II”) and Taiwan Food and Drug Administration Letter FDA Yào- Zì No. 1000017608, Apr. 12, 2011, which instructed that “…. Explanation 3: Also, according to Article 50 of the Pharmaceutical Affairs Act Enforcement Rules, so-called ‘urgent need of medical treatment services’ means circumstances in which a physician at a medical care institution, due to urgent need for medical care measures, must immediately use a drug; furthermore, so-called ‘must immediately use a drug’, means physicians must administer injection and oral medication on the spot due to urgent need for medical care measures.” (hereinafter “Disputed Letter”) exceed the scope of authorization by the enabling statute. The petitioner thereby brought an action to this Constitutional Court for an interpretation. This Court decided that the action complied with the requirements set forth in Article 5, Paragraph 1, Subparagraph 2 of the Constitutional Court Procedure Act and should be admitted. We hereby render this Interpretation based on the following reasons:
I. Disputed Provision I Do Not Contravene the Constitutional Intent of Protecting People’s Right to Work.
According to Article 15 of the Constitution, people’s right to work shall be guaranteed (see J.Y. Interpretation Nos. 404, 510, 612, and 637). The Constitution has set forth different standards of permissibility, based on different contexts, as to restrictions on the freedom to choose an occupation. The legislators, in pursuance of the general public interest, may impose proper restrictions on the methods, time, location and content in regard to which an occupation may be carried out. Yet on the freedom to choose an occupation, if [the restrictions] concern the requirements based on subjective condition, which means professional capability or license to perform the specific occupation, and such capability or [license] status can be gained through training and development, such as knowledge, degree or physical capability, no restrictions may be permitted without justification of important public interest. To the contrary, the objective condition required for people to choose an occupation means those restrictions on the pursuance of an occupation that cannot be achieved by individuals’ efforts, such as monopoly of certain sectors. Such restrictions may be justified only with the showing of an extraordinarily significant public interest. Furthermore, irrespective of whether the restrictions imposed relate to the freedom to practice an occupation, or subjective and objective conditions to the freedom of choosing an occupation, the means adopted must not violate the Principle of Proportionality (see J.Y. Interpretation Nos. 649).
Before two years of the implementation of the National Health Insurance, besides diagnosis, duty to inform, administering treatment (including administering drugs directly), issuing prescription, physicians have complete privilege and duty to treat patients including dispensing drugs for a purpose of treatment and delivering drugs (see Article 11, Article12-1, Article13 and Article14 of Physicians Act and Article 102 of the Pharmaceutical Affairs Act). Thus, for the purpose of treating patients by physicians, dispensing and delivering drugs to take was a portion of medical treatment as a whole and also methods and contents for physicians to practice their occupation, which was guaranteed under the right to work, according to Article 15 of the Constitution.
Disputed Provision I provides: “After two years of the implementation of the National Health Insurance, the provision of the preceding Paragraph shall be enforceable only in the remote areas where practicing pharmaceutical personnel are not available as announced by the central or municipal competent health authorities or in the case of urgent need of medical treatment services.” Therefore, after two years of the implementation of the National Health Insurance, unless in the remote areas where practicing pharmaceutical personnel are not available as announced by the central or municipal competent health authorities or in the case of urgent need of medical treatment services, any physician shall not dispense drugs by himself/herself. Such restrictions infringe on physicians’ freedom of practicing their occupation for treating their patients. Further, there is no violation of the Principle of Proportionality as long as the legislators [only] pursue a general public interest, the restrictions serving to assist in achieving that purpose, and there being no alternatives to accomplishing the same purpose with less detrimental means available, provided that there is due proportionality between the critical nature of the public interests to be maintained and the degree of damage to the public interest caused by the restrictions (see J.Y. Interpretations Nos. 738).
Originally, there was no such Disputed Provision I when Executive Yuan sent the draft amendment of “Pharmaceutical Product and Firm Act” to be reviewed by Legislative Yuan in 1986. The title of “Pharmaceutical Products and Firms Act” was changed into “Pharmaceutical Affairs Act” by the resolution of the 84th Sessions, 6th setting of Joint Session of Internal Administration Committee and Judiciary Committee in the December 20, 1989. At the same time, an Article 102, Paragraph 2, which provides “after two years of the implementation of the National Health Insurance, the provision of the preceding Paragraph shall be enforceable only in the remote areas where practicing pharmaceutical personnel are not available as announced by the provincial (municipal) competent health authorities or in the case of urgent need of medical treatment services” was amended by the resolution of the 89th Sessions, 13th setting of Joint Session of Internal Administration Committee and Judiciary Committee in the July 8, 1992 (see the Legislative Yuan Gazette 79(62): 19; 81(59): 396). Later, because of the modifications of the functions, operations, and organization of the Taiwan Provincial Government, the abovementioned article was revised into Disputed Provision I by Legislative Yuan in April 11, 2000 (see the Legislative Yuan Gazette 89(16): 36,39). In conclusion of the discussion during the legislative process, Disputed Provision I was amended for the purpose of separating pharmacy from medicine which consequently separates prescribing and dispensing in order to allow pharmacists to check and review prescriptions issued by physicians with their professional knowledge and skills for medication safety of people (see the Legislative Yuan Gazette 81(57): 380,381,383,385,386,388). Such purpose is legitimate.
The measure which adopted by Disputed Provision I to restrict physicians’ privilege of dispensation is helpful for achieving the purpose that pharmacists are able to re-check the correctness of the prescribed medicine during dispensation. In addition, there is no alternatives to accomplishing the same purpose with milder means available so the measure does not go beyond the extent of necessity. Furthermore, although Disputed Provision I restricts physicians’ privilege of dispensation, such restriction does not interfere with all or the core parts of the contents and methods regarding physicians' practice, such us diagnosing diseases, administering treatment and prescribing medicine). As a result, after measuring the harm to physicians’ right to work and the public interests to be protected by Disputed Provision I, there is not imbalance between the harm and pursued interests brought by the measure adopted by the legislators.
In summary, Disputed Provision I falls under the constitutional mandate of the principle of proportionality under Article 23 of the Constitution and is not in contravention of the constitutional guarantees of people’s right to work under Articles 15 of the Constitution respectively.
Both Disputed Provision II and Disputed Letter violate the Gesetzesvorbehalt principle
A restriction placed on freedom and right must be prescribed by law or by regulations explicitly authorized by law (see J.Y. Interpretations Nos. 394, 443, 559, 710, 711). When setting forth the applicable enforcement rules by the authorization of law or issuing interpretations, letters and regulations by its own authority involving restriction of people’s rights, the competent authority does not violate the Gesetzesvorbehalt principle if it complies with the view of the general legal construction methodology and is consistent with the relevant constitutional principles and legal intentions (see J.Y. Interpretations Nos. 566, 611, 751).
To fulfill a requirement from Article 105 of Pharmaceutical Affairs, the competent authority set the Pharmaceutical Affairs Enforcement Rules, in which Disputed Provision II provides that “‘urgent need of medical treatment services’, as used in Article 102, Paragraph 2 of the Act, means circumstances in which a physician at a medical care institution, due to urgent need for medical care measures, must immediately use a drug.” In addition, Disputed Letter explains that the ‘must immediately use a drug’ mentioned in Disputed Provision II means physicians must administer injection and oral medication on the spot due to urgent need for medical care measures.” Therefore, under the interpretation derived from Disputed Provision II and Disputed Letter, the situation of ‘urgent need of medical treatment services’ mentioned in Disputed Provision I is limited to a circumstance in which a physician at a medical care institution, must administer injection and oral medication “immediately” or “on the spot”, due to urgent need for medical care measures.
However, circumstances with urgent need of medical treatment services are diverse. At the same time, circumstances with patients’ urgent need of drugs are not limited to immediate or on-the-spot needs. Nevertheless, the competent authority also acknowledged that, besides the need to use drugs immediately or on-the-spot, if patients have urgent need of taking medicine continuously to avoid harms to their lives and health, physicians may administer spare medicine additionally before approaching pharmacist’s dispensation (see Ministry of Health and Welfare Letter Wei-Shou-Shih-1079039725 response to Taiwan Medical Association of February 12, 2019.) Such letter reflects that Disputed Provision II and Disputed Letter limit circumstances with urgent need of medical treatment services into a single situation in which physicians need to use drugs immediately or administer injection/oral medication for urgent medical procedure. Such limitation shrinks the scope of the meaning of “circumstances with urgent need of medical treatment services” provided in Disputed Provision I too much, imposes restrictions on the right not otherwise found, contradicts the enabling statute’s purpose in responding to the urgent medical needs and protect patients’ interests as a whole, exceeds the scope of authorization by the enabling statute and is thus inconsistent with the Gesetzesvorbehalt principle in Article 23. Disputed Provision II shall be null and void immediately from the date of announcement of this Interpretation; Disputed Letter shall be not applicable as of the promulgation date of this interpretation.
Additional Points to Note
The purpose of Disputed Provision I is to implement the policy of separating pharmacy from medicine. Such policy has been chosen by the Legislature. Therefore, the constitutional interpreters should respect such choice in principle. Before any change of such policy is made, authorities concerned should fulfil the accessibility and convenience of community pharmacy as soon as possible under the legislative purpose of Disputed Provision I in order to protect people’s interests to acquire pharmacist’s services of dispensing drugs. Before the system is optimized into prefection, authorities concerned shall evaluate whether Disputed Provision I has created enough leeway for physicians to dispense drugs under exceptional situations for the protection of patients’ medical interests to the highest extent. In addition, they shall review and make reasonable adjustment duly, according actual development level of separating pharmacy from medicine. It is also noted here.
Petitions Dismissed
Petitioner also asserted that there is an issue with the potential unconstitutionality of Taiwan Food and Drug Administration Letter FDA Yào- Zì No.1020022537, Jun. 5, 2013 because of violating the Gesetzesvorbehalt principle. This court finds that the aforementioned letter was Taiwan Food and Drug Administration’s response to the Department of Health, Taipei City Government’s inquiry for the petitioned case. The nature of such letter is not an abstract regulation for general matters at all, Accordingly, such letter is not a law or regulation under Article 5, Paragraph 1, Subparagraph 2 of the Constitutional Court Procedure Act to be the permissible object of the petition for constitutional interpretation. Therefore, such part of the petition is not made in accordance with Article 5, Paragraph 1, Subparagraph 2 of he Constitutional Court Procedure Act, and is thus dismissed in accordance with Article 5, Paragraph 3 thereof.
______________________
* Translated by Wan-Tsui Chiang.