Menuju Implementasi Hasil Riset Vaksin
Kemandirian vaksin tak bisa terwujud tanpa dukungan hasil riset yang mumpuni. Hal itu tak mudah dilakukan tanpa kerja sama yang baik antara periset, industri, dan pemerintah. INOVASI pembuatan vaksin di Indonesia tertinggal 15 hingga 20 tahun di belakang negara maju.Kondisi tersebut menyebabkan pemenuhan kebutuhan vaksin di Indonesia tergantung pada teknologi asing. Padahal, penanggulangan penyakit di sebuah negara tidak bisa sepenuhnya menggantungkan diri pada negara lain. “Urusan penyakit itu tidak boleh bergantung pada siapa pun. Ketika ada wabah SARS, misalnya, apa negara lain mau bantu? Belum tentu. Mereka juga takut untuk datang ke kita,“ ujar Direktur Utama PT Bio Farma Iskandar dalam Forum Riset Vaksin Nasional (FRVN) ke-IV di Jakarta, Selasa (19/8). Karena menyadari hal itu, pihaknya bersama Kementerian Riset dan Teknologi (Kemenristek) beserta Kementerian Kesehatan (Kemenkes) menggagas Forum Riset Vaksin Nasional sejak 2011 lalu. FRVN berhasil memfasilitasi terbentuknya lima konsorsium dan tujuh working group yang bertujuan mencari inovasi terbaru penanganan penyakit. Forum tersebut memediasi ketidaksepahaman antara tiga pihak, yakni periset, industri dan pemerintah, agar mampu menghasilkan produk biologi yang bisa diproduksi secara massal. Iskandar menyatakan bahwa selama ini banyak penelitian yang terputus di tataran laboratorium saja. Ia juga melihat banyak peneliti yang berkutat pada isu yang sama tapi tidak nyambung satu sama lain. Hal itu terjadi karena tidak ada arah yang jelas terkait target akhir penelitian. Untuk itu, langkah pertama FRVN, khususnya Bio Farma, adalah memersuasi para peneliti untuk menyamakan pandangan terkait target akhir penelitian.Di sisi lain, Kemenristek mengucurkan Rp15 miliar per tahun untuk lima konsorsium sebagai dukungan pendanaan penelitian. “Researcher itu seperti seniman, jadi susah diatur. Tapi, ternyata bisa juga. Mereka mau meruntuhkan dinding penyekat itu,“ cetusnya. Menginjak tahun ke-4, sejumlah konsorsium mulai menunjukkan hasil atas riset yang dilakukan. Konsorsium Hepatitis B dan konsorsium Eritropoetin (EPO) atau biosimilar dinilai menunjukkan kinerja yang lebih menonjol jika dibandingkan dengan tiga konsorsium lainnya. Kedua konsorsium tersebut menunjukkan riset yang dihasilkan mulai mendekati target utama. Hasil yang didapat itu akan dipaparkan di hadapan anggota konsorsium lain. Selanjutnya, hasil tersebut akan dikaji kembali oleh perwakilan dari Kemenristek, Dirjen Litbangkes Kemenkes, dan Bio Farma, untuk menentukan tahapan selanjutnya. Ia mengharapkan hasil positif bisa didapat agar pada tahun ke-5, tahapan riset sudah masuk tahap pengujian untuk produksi (scale up). “Kami akan sampaikan informasi itu di depan anggota konsorsium lainnya. Dengan itu, kami bisa perlihatkan bahwa ada dua konsorsium yang terarah dan menuju industri. Diharapkan, bisa memotivasi konsorsium lainnya,“ sahut Ketua Panitia FRVN ke-4 Erman Tritama. Terkait tiga konsorsium lainnya, ia menyatakan bahwa perkembangan penelitian berjalan lebih lambat akibat masalah kelengkapan data. Untuk itu, fokus ketiga konsorsium masih dalam tahap pengumpulan data.“Vaksin hepatitis B itu sudah ada di dunia sehingga patokannya lebih jelas. Tapi, bukan berarti lebih mudah juga,“ imbuhnya.Dukungan pemerintah Menristek Gusti Muhammad Hatta menyampaikan apresiasinya terkait kemajuan riset yang dicapai konsorsium yang tergabung dalam FRVN. Ia sepakat jika koordinasi dan sinergi menjadi masalah yang menghambat pengembangan riset di Indonesia, termasuk vaksin.Kehadiran FRVN dinilai strategis dalam mengatasi hambatan yang ada. “Konsorsium ini bersifat terbuka, profesional, dan tidak birokratik. Ini penting supaya jangan lama-lama lah,“ ujarnya. Meski begitu, ia mengakui jika masih ada masalah lain yang tidak bisa ditangani sendiri oleh FRVN. Salah satunya adalah penerapan sistem birokrasi yang bertele-tele. Masalah yang bersifat administratif itu menyebabkan kerja peneliti tidak optimal. Mereka sering kali harus menganggur selama beberapa bulan akibat pengadaan bahan baku yang terhambat. Hal senada diakui Dirjen Bina Kefarmasian dan Alat Kesehatan Kemenkes Maura Linda Sitanggang. Untuk itu, pihaknya berupaya untuk meningkatkan koordinasi dan komunikasi dengan sektor terkait. Namun, ia juga mengharapkan agar sektor lainnya berlaku responsif.Dengan begitu, hambatan yang diakibatkan sistem birokrasi bisa ditangani lebih baik. “Kalau urusan antarpemerintah ini berarti presiden yang harus bermain supaya bisa terkoordinasi. Masalah ABG (akademisi, bisnis, pemerintah) ini mudah dikatakan, tapi untuk dilaksanakan, ada seninya tersendiri,“ tukasnya. (S-25) dinny@mediaindonesia.com Sumber: Media Indonesia 20 Agustus 2014
The Self-Reliance of the vaccine can not be realized without the support of a qualified research results. It was not easy to do without the good cooperation between researchers, industry, and government. INNOVATION of vaccine manufacturing in Indonesia has left 15 to 20 years behind the developed countries. This condition lead to the fulfillment of the needs of the vaccine in Indonesia depends on foreign technology. In fact, prevention of disease in a country can not fully rely on other countries. "In teh matter of the disease should not be dependent on anybody. When there is an outbreak of SARS, for example, what other countries want to help? Not necessarily. They are too afraid to come to us, "said President Director of PT Bio Farma, Iskandar in the National Vaccine Research Forum (FRVN) to IV in Jakarta, Tuesday (19/8). Realizing this condition, with the Ministry of Research and Technology (Kemenristek) and the Ministry of Health (MOH) initiated the National Vaccine Research Forum since 2011. FRVN managed to facilitate the formation of five consortiums and seven working groups that aim to find the latest innovations of disease management. The forum mediate the disagreements between the three parties, namely researchers, industry and government, to be able to produce a biological product that can be mass produced. Iskandar stated that during this time many studies had been interrupted in the laboratory level only. He also saw a lot of researchers who dwell on the same issue but do not connect to each other. It happened because there was no clear direction related to the end target of the study. For that, the first step FRVN, especially Bio Farma, persuaded the researchers to equate the views related to the final target of the research. In other hand,the Minister of Research and Technology disburse Rp 15 billion per year for five consortium as rthe esearch funding support. "The Researcher is similar to artists, they are unruly. But, it can also be. They want to tear down the partition wall, "he said. Stepping on the 4th year, a number of consortium began to show results on research conducted. Hepatitis B Consortium and erythropoietin Consortium (EPO) or biosimilar are considered showing performance that is more prominent when compared to three other consortium. The both consortium shows the resulted research began to approach the main target. The results obtained will be presented in front of the other consortium members. Furthermore, these results will be reviewed by representatives of the Minister of Research and Technology, Directorate General of Research, Development, and Health of the Ministry of Health, and Bio Farma, to determine the next stage. He expects that the positive results can be obtained in order that in the 5th year, the research stage has entered research stage for the production (scale up). "We will deliver the information in front of the other consortium members. With it, we can show that there are two consortium focused and toward the industry. Hopefully, it can motivate other consortium, "said the Committee Chairman of 4th FRVN Erman Tritama. Relating to the three other consortiums, he stated that the development of research goes slower due to data issues. For that reason, the third focus of the consortium is still in the stage of data collection. "The hepatitis B vaccine was already in the world so that its standard is clearer. However, it does not mean easier as well." he said. The government support through the Minister of research and Technology, Gusti Muhammad Hatta expressed his appreciation related to the research progress achieved by the consortium incorporated in FRVN. He agreed that coordination and synergy become problems that hinder the development of research in Indonesia, including vaccine. The presence of FRVN considered strategic in overcoming the existing barriers. "The consortium is open, professional, and not bureaucratic. This is important so it doesn't take a long time, "he said. Even so, he acknowledged that there are still other problems that can not be handled by FRVN alone. One of them is the implementation of the bureaucratic system that is compliceted. The dministrative problems that led to the work of researchers is not optimal. They often have to be unemployed for a few months due to the procurement of raw materials hampered. The same thing is acknowledged by the Directorate of Pharmaceutical Services and Medical Devices of the Ministry of Health, Maura Linda Sitanggang. For that reason, it seeks to improve coordination and communication with other sectors. However, he also hoped that other sectors apply responsive. So, the constraints imposed by bureaucratic system could have been handled better. "If it is the intergovernmental affairs, the president must be involved so it will be well coordinated. The ABG Problem (academia, business, government) is easy to say, but it needs art to implement them, "he said. (S-25) dinny@mediaindonesia.com Source: Media Indonesia August 20, 2014