論醫藥品之近用權－以強制授權為中心

A study on the right to access to medicines: from the compulsory license perspective

張韶庭(Shao-Ting Chang)

指導教授 ： 陳文吟

國立中正大學/法學院/財經法律學系/碩士(2014年)

摘要

印度為全球製藥產量位居第四名之國家，惟其卻於西元2012年3月9日首次核准境內學名藥廠Natco Pharma Ltd.強制授權製造專利醫藥品，由此可知，即便製藥技術發達之國家亦潛在醫藥品近用權保障未周之疑慮。

如何保障醫藥品近用權，包含醫藥品專利、真品平行輸入、學名藥之生產與強制授權等方式，而強制授權乃提升民眾醫藥品近用權最有效率之方法，惟核准強制授權通常伴隨醫藥品專利權人收益降低之結果，致其欠缺資金無法順利進行研發，進而抑制其發明之動力。其次，開發中國家為引進投資與技術轉移，避免使投資者認為其漠視專利權之保障而紛紛走避，其寧願否准強制授權之申請，以維繫其與投資者之良好關係。第三，TRIPs理事會雖依杜哈公共衛生宣言第六段指示作成決議，申明無製藥能力或製藥能力不足之WTO會員得排除TRIPs協定第31條第f款之適用，進口他會員強制授權製造之醫藥品，然而，由於販售強制授權製造之醫藥品僅可獲得微薄利益，多數醫療水準先進國家對於申請強制授權製造專利醫藥品，以輸出至無製藥能力或製藥能力不足之WTO會員通常興致缺缺，導致此等國民對於專利醫藥品之需求仍無從獲得滿足。

為解決強制授權引發之缺失，本文建議，首先應凝聚全球建立健康世界之共識，藉由WTO、非政府組織、各國政府與各產業企業之合作及各國於內國法增訂強制授權相關規範之方式，吸引已開發國家藥廠投資進駐，增加該藥廠強制授權製造專利醫藥品，協助無製藥能力或製藥能力不足之國家之意願。此外，將強制授權核准與否之爭議訴諸公正第三人－WTO爭端解決機制，由其客觀分析TRIPs協定強制授權要件進而公開作出決策，得確保強制授權核准一致性，建立製藥業者之信心，並得消弭已開發國家與開發中國家二者間貿易上之緊張關係，減少前者對後者核准強制授權之行為採取經濟削弱貿易制裁之情形發生，以排除後者擔憂核准強制授權所帶來之負面結果。藉由前述步驟之踐行，患者之醫藥品近用權將可獲得妥適之保障，使現代醫學科技發達之成果更廣泛地分享予全球人民，降低疾病之死亡率以提升其健康狀態並延長壽命，如此一來，落實健康世界之目標即不遠矣。

我國專利法於民國100年進行大幅度之修改，並針對強制授權之事由增列其他重大緊急情況，惟綜觀多國強制授權規範大致包含「公共利益」與「未於境內實施」二要件可知，我國現行專利法關於「未於境內實施」之強制授權要件仍有待補充。因此，回復訂定民國83年前專利法「無正當理由未於國內實施或未適當實施」之強制授權事由，以完善強制授權制度，遵循TRIPs協定第2條應遵守巴黎公約第5條之規範實有必要。

關鍵字

醫藥品專利 ； 學名藥 ； 真品平行輸入 ； 杜哈公共衛生宣言 ； 強制授權 ； 醫藥品近用權 ； 特許實施 ； 索拉菲尼

並列摘要

Indian pharmaceutical industry is the fourth largest in the world in terms of volume. However, Indian Patent Controller issued the first compulsory license to Natco Pharma Ltd. on 9 March 2012, and it reflected a potential problem that patients' right to access to medicines is not completely protected in India.

There are many ways to enhance the right to access to medicines, including pharmaceutical patents, parallel imports, production of generic drugs and compulsory licensing. Compulsory license is the most efficient way to improve the right to access to medicines, but it usually results in low revenue, letting pantentee lack of funds to research on new drugs and give up invention. Secondly, developing countries usually choose to reject compulsory application to maintain good relationships with developed countries for the sake of attracting investment and technology transfer. Thirdly, the Council for TRIPs adopted the instruction of paragraph 6 of the Doha Declaration and made a resolution waiving obligation under Article 31(f) of the WTO members with insufficient or no manufacturing capacities in pharmaceutical sector, permitting them to import medicines made under compulsory license from other members. However, many members which have excellent pharmaceutical technology are not willing to apply compulsory license to produce patented medicines and export to other members with insufficient or no manufacturing capacities in pharmaceutical sector because selling medicines made under compulsory licensing only makes a meager profit. Patients' right to access to medicines is still not completely protected in the end.

In order to solve defects caused by compulsory licensing, it is necessary to reach worldwide consensus on building a healthy world. Developed countries would be willing to invest, apply for patents and produce patented medicines under compulsory license for developing countries with WTO, NGOs, governments and various industries’ cooperation and formulating relevant regulations about compulsory license in domestic law. Besides, pharmaceutical industry would continue developing new medicines and developed countries would stop trade sanction against developing countries which approved compulsory license if an impartial third party-DSB analysis conditions about compulsory license of TRIPs Agreement openly and make a decision on compulsory license publicly.Following these steps, patients' right to access to medicines would be completely protected and they could increase chances of taking new medicines to cure diseases. Therefore, the goal of building a healthy world would be achieved more easily.

Our patent law was amended comprehensively in 2011, and it increased "other circumstances of extreme urgency" as a reason of compulsory license. However, observing many countries' reasons of compulsory license, we can find that most of them include public interests and failure to worke in domestic territory. Therefore, it is necessary to include non-working or insufficient-working as thr cause of compulsory license by conferring our 1994 Patent Law. By doing so, the system of compulsory license would be more completed, and our patent law would be more in compliance with Article 2 of TRIPs Agreement which requires members to comply with Articles 5 of the Paris Convention.

並列關鍵字

generic drugs ； parallel imports ； Doha Declaration ； compulsory license ； the right to access to medicines ； pharmaceutical patent ； Sorafenib tosylate

參考文獻

1、行政院衛生署，藥品非臨床試驗安全性規範，第2頁，民國87年。

4、 陳文吟，探討因應醫藥品專利之合理措施，中正大學法學集刊，第8期，第71頁，民國91年。

7、 蕭振寰，台灣加入GATT/WTO的歷史回顧，台灣國際法季刊，第二卷第二期，第335-337頁、第355頁，民國94年。

2. BODENHAUSEN, G.H.C., GUIDE TO THE APPLICATION OF THE PARIS CONVENTION FOR THE PROTECTION OF INDUSTRY PROPERTY 69-71.

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