Measuring Progress of Regulatory Convergence and Cooperation Among Asia–Pacific Economic Cooperation (APEC) Member Economies in the Context of the COVID-19 Pandemic

Purpose Regulatory convergence and cooperation among medical product regulatory authorities are essential to delivering safe and efficacious products quickly to patients. The COVID-19 pandemic highlights the urgent need for streamlined regulatory approval processes—which can be achieved in part through regulatory convergence and cooperation—both to accelerate availability of COVID-19 vaccines, treatments and diagnostics and to maintain the availability of the existing medical products unrelated to COVID-19. Methods The Asia–Pacific Economic Cooperation (APEC) Life Sciences Innovation Forum (LSIF) established the Regulatory Harmonization Steering Committee (RHSC) in 2008 to advance regulatory convergence among APEC’s 21 member economies. Key performance indicators (KPIs) were developed in 2018 to measure convergence. Results This paper reports survey results collected from KPI tracking in March 2020 from medical product regulatory authorities in all 21 APEC economies concerning areas of regulatory practice in which they could converge and cooperate. For example, from 2008 to 2020, there was a 14.3% increase in the number of APEC member economy regulatory authorities sharing Good Manufacturing Practices (GMP) Certificates and a 28% increase in the number of regulatory authorities accepting multisite licenses in that same period. In addition, this paper explores how APEC economies could realize a maximum level of regulatory convergence and cooperation. Conclusions Convergence efforts within APEC can accelerate availability of medical products including that related to COVID-19 vaccines, treatments and diagnostics, while maintaining the availability of the existing medical products unrelated to COVID-19 vaccines and treatment. New KPIs and capability building are to be considered to enable a new era of innovation ushered in by COVID-19.

THE DISPOSITION OF INDIVIDUAL АРЕС COUNTIES IN THE GLOBAL ECONOMIC ENVIRONMENT

The formation of a new global system and systemic global interdependence generates new factors of com- petitiveness of market participants, determining their appropriate strategic behavior to ensure a high competitive position and leadership. This determines the relevance of the research topic. The aim of the study is to determine the peculiarities of the deve¬ lopment of individual countries and key determinants of advanced development in Asia which are members of the Asia-Pacific Economic Cooperation. The following research methods were used in the article: models of multifactor regression, cluster analysis, methods of comparative analysis. Method (methodology). Using a multifactor regression model and cluster analysis, four clusters of countries were identified according to key indicators of intellectual leadership. For each cluster, the specializa- tion of the two countries in terms of merchandise exports was analyzed, namely, 1 cluster – the United States and Germany; 2nd cluster – Israel and Italy; 3rd cluster – Brazil and Ukraine; Cluster 4 – China and the Republic of Korea. Based on the author’s methodology for assessing the intellectual leadership of countries, the clustering of countries in the global economy is determined. The evaluation algorithm was based on three stages: first – the resource level; secondly – the level of intermediate results of intellectual activity; third – the level of the final results of overall progress. Based on clustering, it is determined that Asian countries are characterized by different from other countries features of development, determined by historical and economic preconditions. addition, the normative basis for the development of human resources in Asian countries which are members of the Asia-Pacific Economic Cooperation, the peculiarities of the production of high-tech goods and the rating of high-tech exports of selected countries are determined. The superdynamic development of Asian countries indicates the formation of a specific cluster on the global economic map, characterized by faster development, significant attention to the development of key factors of intellectualization and increasing their own positions in global rankings.

PENTINGNYA PERLINDUNGAN HUKUM KEKAYAAN INTELEKTUAL BAGI PEMBANGUNAN EKONOMI INDONESIA

Pembangunan ekonomi suatu negara berkaitan erat dengan perlindungan Kekayaan Intelektualnya. Semakin tinggi penghargaan negara terhadap Kekayaan Intelektual, akan merangsang pertumbuhan ekonomi. Kekayaan intelektual adalah hak yang timbul dari hasil olah pikir untuk menghasilkan suatu produk atau proses yang bermanfaat. Pada intinya kekayaan intelektual adalah hak untuk menikmati secara ekonomis hasil dari suatu kreativitas intelektual. Indonesia memiliki komitmen yang sangat kuat terhadap perlindungan Kekayaan Intelektual baik yang bersifat nasional, regional maupun internasional. Hal ini dapat dilihat dengan: Dibentuknya Undang-Undang Nasional di bidang Kekayaan Intelektual, yaitu tentang: Hak Cipta, Merek Dan Indikasi Geografis, Paten, Desain Industri, Desain Tata Letak Sirkuit Terpadu, Perlindungan Varietas Tanaman dan Rahasia Dagang; Ikut ambil bagian dalam Persetujuan/Perjanjian Kerangka Kerja ASEAN (ASEAN Frame work Agreement) dan Asia-Pacific Economic Cooperation (APEC) dalam agenda kerja Osaka; Menjadi anggota Organisasi Perdagangan Dunia World Trade Organization (WTO) menyiratkan bahwa Indonesia secara otomatis terikat pada TRIPs; Meratifikasi World Intellectual Property Organization (WIPO). Pembentukan hukum Kekayaan Intelektual harus tetap memiliki orientasi pada kepentingan nasional dengan tetap memperhatikan ketentuan-ketentuan internasional. Perlindungan hukum Kekayaan Intelektual di Indonesia berpegang pada teori keadilan yang berdasarkan pada Pancasila, dengan prinsip-prinsip: Kemanusiaan; Keseimbangan kepentingan individu dan masyarakat; Nasionalisme; Keadilan sosial dan Pengembangan ilmu pengetahuan dan teknologi (iptek) tidak bebas nilai (berdasarkan nilai-nilai Pancasila). Meskipun telah dibentuk dan diberlakukan berbagai peraturan di bidang Kekayaan Intelektual, masih terdapat banyak permasalahan-permasalahan. Hal ini dipengaruhi berbagai faktor, antara lain: Berkaitan dengan substansi, struktur, dan budaya (kultur) hukum. Penelitian ini membahas tentang: Bagaimana pelaksanaan perlindungan hukum Kekayaan Intelektual bagi pembangunan ekonomi Indonesia dan Permasalahan apa saja yang ditemukan dalam pelaksanaan perlindungan hukum Kekayaan Intelektual bagi pembangunana ekonomi Indonesia. Metode yang digunakan adalah yuridis normatif. Untuk mengatasi permasalahan tersebut, maka dibutuhkan adanya solusi agar tercipta apa yang menjadi tujuan dari perlindungan hukum Kekayaan Intelektual yaitu terwujudnya keadilan.