Healthcare & Medical Law

The firm is arguably at the forefront of healthcare and medical law practice in Malaysia. The practice was initiated in the mid-1990’s and it has since developed into one of the largest dedicated healthcare and medical law practice groups in Malaysia. We are one of the few legal firms in Malaysia in a position to provide comprehensive advice and representation for all players in the healthcare industry. Our decades of experience have allowed us to gain a wealth of knowledge and practical understanding of the discipline and practice of medicine, dentistry and its related industries and enabled the firm to establish substantial contacts with various medical/dental associations and regulatory bodies.

Our courtroom experience is extensive and our lawyers regularly appear in trials and appeals involving healthcare practitioners and hospitals. We handle numerous matters before various levels of tribunals and courts, many of which extend to cases involving allegations of misdiagnosis, surgical mishaps, delayed treatment, the use of inappropriate equipment/devices, conflicts of interests and the use of controversial drugs. We are also familiar with matters pertaining to professional ethics as we commonly represent healthcare practitioners in disciplinary inquiries held by the Malaysian Medical Council and the Malaysian Dental Council established under the Ministry of Health. 

Further, our practice also includes advising clients on legal developments as well as compliance with relevant legislation such as the Medical Act 1971 and the Private Healthcare Facilities and Services Act 1998. 

We are often consulted to assist in crisis and reputation management, particularly during the occurrence of an adverse medical event. As lawyers, we assist in foreseeing the likelihood of litigation arising from such adverse events and we guide our clients on the best possible steps to take. The issue of media often arises in parallel and we ordinarily assist clients in refining their responses in such situations. Given the emergence of technology, our advice is also sought as to the legal positions of new innovations in healthcare, including new features of medical technology and applications.

With the onslaught of the Covid-19 pandemic, healthcare and its surrounding legal issues have become a substantial item of concern. The healthcare and medical law team in our firm was well-prepared to provide guidance to clients and stakeholders in the Malaysian healthcare industry. For example: 

  • we were engaged by the Association of Private Hospitals of Malaysia to advise its members on the private-public healthcare partnership that was much needed to address the demands that arose due to the pandemic;
  • healthcare practitioners who faced investigation and prosecution under various healthcare-related provisions, including investigations carried out by the Ministry of Health and the then Ministry of Domestic Trade and Consumer Affairs on healthcare-related price-controlled goods pronounced during the pandemic were provided with advice and support;
  • members of the RDL healthcare and medical law team authored articles to address several complex medico-legal and medical ethics issues that arose due to the pandemic, including issues relating to patient honesty and the right of practitioners to refuse to treat patients;
  • webinars were also organised during the period of the Movement Control Order in Malaysia.

The Covid-19 pandemic may well prove to be the catalyst that has sped up the growth of businesses involved in virtual healthcare consultations and digitalisation of healthcare in Malaysia. The firm has been actively consulted by both domestic and foreign players on regulatory compliance relating to such matters. Our assistance extends to representation of our clients in disputes with regulatory bodies and authorities. We were also involved in discussions conducted by the Ministry of Health relating to the digitalisation of healthcare in Malaysia and discussions by the Malaysian Productivity Corporation held by the Private Healthcare Productivity Nexus on Telemedicine. 

Some examples of regulatory matters on which the firm has advised include:

  • the management of healthcare facilities (taking into account developments of the law on non-delegable duties and vicarious liabilities);
  • the conduct of the practice of tele-medicine (from abroad into Malaysia or within Malaysia);
  • Malaysian laws and regulations affecting the pharmaceutical and cosmetic industries (including but not limited to labelling laws, poisons control, medical advertisement restrictions etc);
  • new offerings in the medical space – the launch of various medical, health and wellness applications (Apps) or other new features of medical technology;
  • accreditation advisory support for hospital groups;
  • the proposed set-up of a rehabilitation facility for patients from the Malaysian public hospitals.

Other than the above, the team has advised on joint ventures and collaborations between Malaysian entities and between Malaysian entities and overseas healthcare service providers, on legal and regulatory controls to establish and operate a hospital, a standalone cardio-facility, a healthcare and research facility and dialysis centres in Malaysia as well as on various other proposals.

The firm also has experience in drafting and vetting agreements in relation to the pharmaceutical industry, such as agreements in respect of clinical trials and bio-equivalence studies, transfers of registration of pharmaceutical products, manufacturing, packaging, distribution and supply of pharmaceutical products, consultancy and maintenance services and the development of pharmaceutical products and generally advising in respect of licensing laws and guidelines. We also vet, review and draft documents such as by-laws, internal policies and template forms relating to the various operations of a hospital and the practice of healthcare practitioners, ranging from standard agreements relating to healthcare services to templates for admissions forms and consent forms. 

Clients

Our clients include general medical practitioners, dental practitioners as well as practitioners in various areas of specialisation, such as obstetricians & gynaecologists, cardiologists, haematologists, oncologists and plastic surgeons. Apart from acting for individual medical/dental practitioners, we advise the Medical Protection Society Limited and the Dental Protection Limited (both of which are based in the United Kingdom), private and public hospitals, various specialist medical associations, pharmaceutical companies and manufacturers of medical devices on various issues such as those relating to statutory, regulatory and ethical requirements. 

Contacts

Partner – Dispute Resolution
+603-2632 9890

eileensoraya@rdl.com.my

Partner – Corporate & Commercial
+603-2632 9882

joyceteh@rdl.com.my

Partner – Dispute Resolution
+603-2632 9904

charlaine@rdl.com.my

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