Legal Opinion on the Implementation of the Act to the Clinical Trial Industry and its Negative Impacts
By Nurul Atiqah Abd Rahman, Siti Nuralis Abd Muis & Siti Nur Hafizah Adnan
Clinical Research Malaysia Legal Department
The Act was announced by Natural Resources and Environment Ministry to be implemented in Malaysia in 2017. It was aimed to regulate the use of biological resources, addresses issues of biopiracy and ensures that result benefits from the access of biological resources are shared equitably. Its content is mainly to conserve and reserve the biodiversity ecosystem in Malaysia for instance, conservation of natural resources like plants, animals but also included the access to human genetic resources. Access to human genetic resources will surely impacted the Clinical Trial Industry in Malaysia. As Clinical Research Malaysia is a company owned by the Ministry of Health Malaysia where we act as a one stop center for Clinical Trial Industry (“the Industry”) in Malaysia we opined that the implementation of the Act will have several negative impacts in the Industry as such our intention in writing this article is to inform the industry and also the relevant parties as to why similar Act should not be implemented to Clinical Trial Industry be it in Malaysia or other countries and how this is actually has been curbed through the initiative taken by Clinical Research Malaysia.
The Act sets out the requirements for access to Biological Resources or Traditional Knowledge associated with Biological Resources for research and development activities whereby the implementation of the Act is to protect the use and access of Biological Resources in Malaysia. Whereas, Clinical Trial is a scientific study that prospectively assigns or conducted on human participants or groups of humans to one or more health-related interventions as a mean to treat, prevent, diagnose or manage various medical condition or diseases and also to evaluate the effects on health outcomes, the inventions may include but are not restricted to drugs (investigational products), devices, surgical procedures, cells and other biological products, radiological procedures, behavioral treatments, preventive care and others. It is human rights that one should have the access to health care. Enforcing the Act to the Clinical Trial Industry would add more steps and more guidelines for a Clinical Trial or Study to be conducted in Malaysia which may lead to the delay in completing the Clinical Trial and may further lead to the depletion of Clinical Trial in future.
Obtaining Permit under this Act
Under the Act, any local or foreign individual or corporation who intends to access Biological Resources or Traditional Knowledge associated with Biological Resources for commercial, or potentially commercial or non-commercial purpose must obtain a permit, violation of this application of permit may cause the relevant party to be penalized. However, a permit may not be required for any research and development activity that is under a public higher education institution, research institution or Government agency within Malaysia, the exchange of Biological Resources between persons within a public higher education, institution, public research institution or Government agency within Malaysia or the access is by any person outside Malaysia or in a private institution within Malaysia from a permit holder who possesses a valid permit to access for the purpose of carrying out or continuing any research for non-commercial purpose.Under the Act, in order to have access to biological resources and to obtain a permit to access biological resources, the accompanying documents required to be submitted along with an application for a permit is the Prior Informed Consent which has to be obtained from Indigenous local community, organization , resource provider or their representative and Benefit Sharing Agreement that has to be entered into with the resource provider who gave access to the Biological Resources or Traditional Knowledge. A Benefit Sharing Agreement under the Act is described as a legally binding contract entered between the person who intends to access the resources or traditional knowledge relating thereto with the resource provider and shall be based upon mutual agreed terms and provide a fair and equitable benefit sharing .
Benefits in Protecting Our Natural Resources!!
In our humble opinion, we do agree that the implementation of this Act may bring a lot of benefit in protecting our natural resources but not when it comes to conducting Clinical Trial which is a solution to provide a better healthcare and medicine to Malaysian citizen. The contention on our stand to oppose the application of the Act to the Industry is substantiate on few comprehensive measures currently exist in Malaysia to regulate and control Malaysian Clinical Trial Industry. First, conducting Clinical Trial in Malaysia already have their own guidelines that spells out the procedures in conducting Clinical Trial or Study such as the Good Clinical Practice guidelines. Second, to regulate and oversee the Clinical Trial or Study conduct as well as to approve the application of import license or exemption of the investigational product/drug, the regulatory body/authority like the National Pharmaceutical Regulatory Agency (NPRA) plays a significant role. Third, the presence of Medical Research and Ethics Committee (MREC) that approves the trial, are sufficient enough as all the protocol, procedures of the Clinical Trial have been examined carefully and thoroughly by the said authority/regulatory body to ensure that it is safe, ethical and further comply with all the requirements and guidelines in conducting Clinical Trial . Fourth, as patients’ consent is the utmost consideration before enrolling them as Clinical Trials subjects, their rights are protected and respected where prior to Clinical Trial is being conducted, informed consent must be obtained from the patients. Legally speaking, the law on contract has evolved as a framework to regulate voluntary exchange transaction. Informed Consent is a voluntary agreement to participate in research. It is not merely a form that is signed but is a process, in which the subject understands the research and its risks. Informed consent is essential before enrolling a participant and ongoing once enrolled. Informed Consent obtained from the patients prior to enrol them as the participating subjects in the Clinical Trial is sufficed to reflect the voluntariness of patients. In Malaysia, the Clinical Trial Informed Consent Form (ICF) shall be reviewed by the ethics committee where the committee itself is comprises of medical background members and lay members. This is crucial as the ICF need to be worded in a layman term so that the patients will not be misled or participating out of undue influence.
The Clinical Trial Agreement (CTA) and its Impact
Fifth, before conducting the Clinical Trial, the relevant party also must have entered into a legally binding agreement known as Clinical Trial Agreement (CTA) which manages the relationship between the Sponsor that may be providing the device or study drug, the financial support and /or proprietary information; the Institution that may be providing data facilities, and/or results; the Principal Investigator and the Study Team that are responsible to conduct the Clinical Trial. The CTA also would describe and acknowledge responsibilities of the relevant party, terms of collaboration, requirements for payment and reimbursement, publication and intellectual property terms, guidelines for dispute resolution, and also terms to ensure the patients’ rights and rights of all the parties who involved in the Study are protected such as indemnification, insurance, subject injury /adverse event clauses. As such the Benefit Sharing Agreement proposed by the Act is certainly not relevant to the Industry.
Sixth, implementing the Act in Clinical Trial Industry, will reduce the number of Clinical Trial or Study and also may further delay any Clinical Trial or Study to be conducted in Malaysia as the Industry/ Sponsor must now obtain permit from the relevant authority and enter into benefit sharing agreement with a resource provider and further adhere to additional requirements and procedures which double up the existing procedure and requirements of Clinical Trial in Malaysia (i.e. Informed Consent Form, Clinical Trial Agreement, existing approval from regulatory bodies).Besides that, it may also decrease the innovation in medical industry in providing and improvise the procedure, techniques, medicine and device to be utilised by the patient in Malaysia to provide a better solution to cure their diseases and providing better healthcare. In other words, the patient would be jeopardised from getting alternative treatment/medicine that could prolong their lives. In fact, the implementation of the Act could also reduce the intangible value of research in sharing technology with other countries , recognition from the world for conducting a quality , reliable trial and expanding resources in order to introduce a better treatment, medicine, therapies, procedure and devices to the patient in Malaysia. It is worth to note that any benefits resulting from the Clinical Trial and its applications should be shared with society as a whole and with the global community. The benefits may take in various forms which includes but not limited to giving special and sustainable assistance to and acknowledgement to those that have taken part in the Clinical Trial or Study, public access to quality health care, access to scientific and technological knowledge, building up facilities for research purpose and any other forms of benefit consistent to the above.
Clinical Research Malaysia (CRM) Views
Clinical Research Malaysia (CRM) viewed that, it is best for every Clinical Trial that is to be conducted in Malaysia and other countries to be exempt from the implementation of this Act or any similar Act considering the benefits of it to the country and the people and further due to the adherence of this industry to the fundamental principles, requirement and regulatory compliance and relevant authority in conducting the Clinical Trial or Study in Malaysia. Further, CRM also actively involved in discussing with the relevant authorities in Malaysia on the negative effects of the implementation of the Act to the Clinical Trial Industry. It is a good action that the enforcement body and authorities in Malaysia now support the rights of the people to participate in Clinical Trial and to receive a better healthcare service and medicine by finally giving exemption to the Clinical Trial from the implementation of the Act commencing 2019 .
 Section 5 of the Access to Biological Resources and Benefit Sharing Act 2017(Act 795)
 Australian Government national Health and Medical Research Council , Department of Innovation, Industry and Science. (2015, April 8). Retrieved from Australian Clinical Trial: https://www.australianclinicaltrials.gov.au/what-clinical-trial (2019, June 11)
 Health Topics, Clinical Trials. Retrieved from World Health Organization:
https://www.who.int/topics/clinical_trials/en (2019, June 11).
 Section 18 of the Access to Biological Resources and Benefit Sharing Act 2017(Act 795)
 Section 22 of the Access to Biological Resources and Benefit Sharing Act 2017(Act 795)
 A Guide to Conducting Clinical Trials in Malaysia. (2016). Society of Clinical Research Professionals Malaysia
 Malaysian Guideline for Good Clinical Practice. (2018). National Committee for Clinical Research (NCCR), National Pharmaceutical Regulatory Agency (NPRA).
Centre for Clinical and Translational Science.. Retrieved from https://ccts.osu.edu/content/clinical-trial-agreement (2019, 11 12)