REGULATORY IMPACT ASSESSMENT DALAM PENYUSUNAN SUATU KEBIJAKAN DI BIDANG OBAT KUASI

The study aimed to assess the impact of costs and benefits analysis(CBA) as an important step in the Regulatory Impact Assessment (RIA) as part and basic concept of Good Regulatory Practices (GRP) principles. CBA is carried out before a policy concerning stakeholder interests was established. CBA was applied to determined that the policies have been taken had greater benefit compare to impact and cost burden by stakeholders. Therefore the policies can be accepted and can be implemented without obstacles by stakeholders. A CBA survey has been conducted among 61 stakeholders, 80% from business actors. Survey as well as identifying problems faced by business actors during the quasi-drug registration process at the Indonesia FDA (BPOM). In addition, information was collected regarding expectations and suggestions for improvement related to the quasi-drug registration process. Assessment of the impact of costs and benefits (CBA) is carried out on two policy alternatives, namely the first alternative does not require a new policy and the second alternative requires a new policy in the form of quasi-drug regulation. The CBA analysis resulted that the benefits have a better value than the cost, if the policy alternative was taken to develop the quasi drug regulation. ABSTRAKPenelitian ini bertujuan untuk menilai manfaat dan dampak biaya (Cost and Benefit Analysis/ CBA) sebagai inti dalam Regulatory Impact Assessment (RIA) sebelum suatu kebijakan ditetapkan. RIA merupakan konsep dasar dalam prinsip-prinsip Good Regulatory Practices (GRP). Penilaian CBA dilakukan sebelum suatu kebijakan yang menyangkut kepentingan luas dari pemangku kepentingan ditetapkan, agar kebijakan memiliki manfaat yang lebih besar dibandingkan dampak biaya yang ditanggung oleh pemangku kepentingan. Sehingga kebijakan dapat diterima dan dilaksanakan tanpa ada hambatan dari pemangku kepentingan. Survei CBA telah dilakukan kepada 61 pemangku kepentingan, 80% adalah pelaku usaha. Survei sekaligus mengidentifikasi masalah yang dihadapi pelaku usaha pada saat proses registrasi obat kuasi di BPOM. Selain itu dikumpulkan informasi terkait harapan dan saran perbaikan terkait proses regsitrasi obat kuasi. Penilaian CBA terhadap manfaat dan biaya (CBA) dilakukan terhadap dua alternatif kebijakan yaitu alternatif pertama tidak perlu ada suatu kebijakan baru dan alternatif kedua, perlunya kebijakan baru berupa peraturan obat kuasi. Hasil analisis CBA diperoleh bahwa manfaat yang lebih baik dibandingkan dampak biaya, apabila alternatif kebijakan yang diambil adalah penyusunan peraturan di bidang obat kuasi.