GUIDANCE FOR BIOSAFETY REGULATORY PROCESS IN BANGLADESH

Transcription

1 GUIDANCE FOR BIOSAFETY REGULATORY PROCESS IN BANGLADESH Khorsheda Yasmeen Deputy Secretary Ministry of Environment and Forests Govt of the People s Republic of Bangladesh

2 2 Outline of the Presentation Defining the Regulatory Process Guidance Background on Regulatory Process in Bangladesh Preview of the Guidance for Biosafety Regulatory Process in Bangladesh Addressing Regulatory Transparency Future Plans

3 3 Defining the Regulatory Process Guidance Guidance is a tool for regulatory bodies to communicate to the stakeholders how they are presently interpreting their regulations It does not confer new powers or obligations on regulators, nor does it create (or remove) legal obligations for stakeholders It is simply a description of how the process is currently functioning Guidance is intended to be informative and current It can be updated frequently to reflect changes in regulatory practice

4 4 Background on Biosafety Regulatory Process in Bangladesh Bangladesh has a long history on Biosafety Regulation Biosafety Guidelines of Bangladesh were earlier formulated by the Ministry of Science and Technology in 1999 Bangladesh signed the Cartagena Protocol on Biosafety (CPB) in 2000 Entered into force in 2004 The Ministry of Environment and Forests (MOEF) is the focal point for the CPB National Biosafety Framework (NBF) is regulatory document 2007 by MOEF Combination of policy, legal, administrative and technical instruments One of the main objectives is to indicate the status of biotechnology and biosafety in the country and what should be done for research and development capacity

5 5 Background on Regulatory Process in Bangladesh Biosafety Guidelines first published in 2008 In accordance with the precautionary Principle 15 of the Rio Declaration on Environment and Development, the objective of this Guideline is to ensure the protection in the laboratory, field trial, safe transfer, handling, use and trans boundary movement of GMOs/LMOs. It is not a final stop in the process. Initiative has been taken to review the guidelines with advancement of science and scientific knowledge, information on risks and the regulations on GMOs. Biosafety Rules finalized in 2012 These create a legally binding status for the Biosafety Guidelines and affirm that they apply to all parties in Bangladesh

6 6 The Biosafety Guidelines describe three relevant levels of regulatory review Institutional Biosafety Committees (IBC) Provide research oversight, and forward applications for regulated activities to the National Committee on Biosafety The National Committee on Biosafety (NCB) Serves as the highest level policy body on biotechnology Chaired by the Secretary of MoEF Membership from all of the relevant Ministries as well as research institutions and NGO representatives The NCB holds the authority for decision making related to biosafety The Biosafety Core Committee (BCC) Technical committee chaired by the Director General of the Department of Environment Provides technical review and advice to the NCB

7 Stakeholders Consultation for updating Biosafety Rules and Guidelines 7

8 8 Additional Committees National Technical Committees Established by decree of the Prime Minister in (year) Related to subject matter and convened by the relevant Ministries E.g. The National Technical Committee on Crop Biotechnology, convened under the Ministry of Agriculture Sometimes stakeholder express their confusion regarding the way the system functions and how they are expected to interface with the regulatory system

9 9 What will the guidance look like? The guidance will provide flow charts for regulatory applications Tailored to the nature of each application The stepwise process will detail how the application will be handled at each step Including expected timelines for reviews and processing Forms and formats for applications will be included Many of these already exist and will be simply included in the guidance for the convenience of stakeholders Step 5 Step 7 Applicant (Principal Investigator) Step 1 Institutional Biosafety Committee Step 2 National Technical Committee on Crop Biotechnology Step 4 National Committee on Biosafety Step 3 Step 6 Core Committee Biosafety Core Committee

10 10 Addressing Regulatory Transparency The South Asia Biosafety Program, with support from MoEF, DoE and the BARC initiated stakeholder engagement on regulatory process Workshop held March 14, 2015 Stakeholders in attendance included government officials from relevant Ministries Researchers and managers from national research organizations Private sector organizations with an interest in biotechnology biosafety regulation The program provided information on the regulatory process in Bangladesh The role and purpose of regulation Reviewing existing regulatory documentation Received feedback from stakeholders encouraging the development of better communication materials Activities done by the committees are uploaded on the MOEF s and DOE s website

11 11 The development of Guidance on Biosafety Regulatory Process in Bangladesh A zero draft has been prepared by the South Asia Biosafety Program This draft has been shared with stakeholders at meetings of the Biosafety Core Committee in August and December 2015 and subsequently modified A stakeholder workshop was held in March 2016 to review aspects of current regulatory practice and discuss additional regulatory process Revisions to the draft guidance are underway with the hope of having a draft completed by the end of 2016

12 12

13 13

14 14 Future Plans The Ministry of Environment and Forests is determined to update the Biosafety Guidelines by this year More stakeholders consultation is needed to finalize it Took necessary action to circulate the guidelines The South Asia Biosafety Program will continue to work with the government and stakeholders to refine the existing document The initial publication will include details of regulatory processes that are well defined, and have been in practice Further regulated activities will be described as those processes are agreed by the Government

15 Thank You 15