Guidelines for Pre- and Post-precision Medicine Counselling Confidentiality

Assoc Prof Fatimah Lateef asked the Minister for Health whether the Ministry will be coming up with guidelines on the appropriate pre- and post-counselling and confidentiality and protection statements for the utilisation of personalised medicine.

Speaker, Personalised Medicine, also known as Precision Medicine, generally refers to the customisation of medical treatments and clinical care to specific patient groups based on their underlying clinical, socio-demographic or genetic profiles. There are existing safeguards on preservation of confidentiality of medical records and informed consent-taking that apply to practice and research in Precision Medicine. These safeguards are provided for under the Private Hospitals and Medical Clinics Act (PHMCA) and the Human Biomedical Research Act (HBRA).

PHMCA stipulates requirements on the protection of medical records, including the confidentiality and integrity of the records. HBRA provides a consent framework for the conduct of human biomedical research, including requirements relating to appropriate consent-taking from research subjects.

Given that the field is evolving rapidly, there is a need to keep abreast of developments and review our safeguards so as to ensure patient and public interests. The Ministry of Health (MOH) has started the process of drafting standards for the provision of clinical genetic testing services in Precision Medicine. These will help address issues, such as pre- and post-test counselling, competency of personnel involved in the delivery of the services, as well as appropriateness in the ordering of genetic tests and interpretation of test results. The need for informed consent, security and confidentiality of information and disclosure of test results to third parties outside direct healthcare providers will also be addressed. MOH will consult relevant stakeholders on the draft standards when they are ready.

Mdm Speaker, I have two supplementary questions for the Minister of State. Firstly, knowing that MOH is drafting the standards, will it amount to a formal clinic practice guideline or a very formal guideline for doctors to follow? Secondly, because this is a relatively new area and the tests can be expensive and also non-standard, can I find out how MOH will be monitoring this space in terms of costing?

I would like to thank Assoc Prof Fatimah Lateef for the supplementary questions. These are, indeed, very pertinent questions. As clinical genetic testing is very new and the field of Precision Medicine is evolving, like I mentioned in my reply, MOH is in the process of drafting standards for the provision of clinical genetic testing applicable for healthcare institutions and laboratories. These sets of standards will be ready by the second half of 2017 and will be promulgated first as a code of practice to all licensees for a year, before being ramped up to make sure that these licensees are operationally ready to meet the draft standards.

Thereafter, these sets of standards will be enforced by the end of 2018, under PHMCA, whereby MOH will set up an inspection and audit mechanism to assess the healthcare institutions' compliance with these standards.

With regard to the second question, all licensees who wish to provide genetic testing services in the healthcare institutions will need to seek approval from MOH and fulfil a set of stringent standards which will include ensuring specialised expertise and qualifications of the medical personnel to interpret test results as well as ensuring proper pre- and post-genetic test counselling to allow patients to make informed decisions and understand the cost benefits of such genetic tests.

MOH's inspection and audit teams will also check that these tests were ordered by qualified medical personnel and counselling was conducted appropriately.