In this edition, we shine the spotlight on key industry happenings, covering the 20th edition of the Code of Pharmaceutical Marketing Practices for Prescription (Ethical) Products, key developments found in the Medical (Amendment) Act 2012 as well as the deadline for submitting applications for the registration of medical devices.
1. New Edition of the Code of Conduct Regarding Pharmaceutical Marketing Practices for Prescription (Ethical) Products (Code)
The Pharmaceutical Association of Malaysia (the PhAMA) has issued the 20th edition of the Code which imposes further restrictions as to how its member companies must interact with medical institutions, healthcare organisations and healthcare professionals (HCPs).
One of the key changes is that the requirements relating to off-label communications, meetings and provision of funding have became more stringent. For example:
- No entertainment, leisure or social activity is to be provided during meetings, save for some background music or cultural performance during meals, offered as part of the dinner package by the food & beverage facility in which the meetings are held.
- The company may continue to cover basic economy travel for speakers and chairpersons. However, the company may only sponsor economy travel of up to 6 hours;
- Now, only the medical or regulatory department of the company is permitted to respond to unsolicited queries from HCPs regarding any unapproved off-label use of a pharmaceutical product.
- Grants and donations should not be provided for the purpose of supporting a recipient’s ordinary business expenses, including for the purchase of infrastructure or overheads.
- A small value promotional aid of not more than RM100 may only be distributed if directly related to the practice of medicine or pharmacy or if of benefit to patient care.
- The statement "For Healthcare Professionals only" must be added to printed materials targeted at HCPs.
Notably, the maximum penalty which the Ethics Committee may impose has been increased by 50% to RM 100,000. The fair market value for a HCP's service fee has also been increased to RM 1,500 per engagement or per day, up to a daily maximum of RM 3,000.
Further, PhAMA has made several editorial amendments in its latest edition of the Code, providing clarifications on, amongst others, the type of interactions covered by the Code; and the process involved where a complaint is made as well as evaluated.
The Code can be found on PhAMA's website here.
2. Recent Changes for the Malaysian Medical Community
The Medical (Amendment) Act 2012 recently came into force on 1 July 2017, making substantial amendments to the Medical Act 1971. To complement the amendments, the Medical Regulations 2017 came into force simultaneously, revoking the preceding Medical Regulation 1974. The amendments are made to accommodate the dynamic developments taking place in the Malaysian health sector.
Some of the key changes are as follows:
- The Malaysian Medical Council ("MMC") is corporatized, providing it with more freedom in funding, with the creation of a fund known as the "Malaysian Medical Council Fund". In addition to receiving government funding, the MMC may generate funding from the services it renders to the medical community as well as utilize the Fund to hire its own employees.
- Pursuant to the corporatization, the MMC also has greater flexibility in managing its secretariat, which shall be made up of elected and appointed members from both the public sector as well as the private sector. As a result, the Malaysian medical community is better represented in the MMC.
- A specialist must be registered as such with the MMC prior to practising in that capacity in Malaysia. The MMC may exercise disciplinary jurisdiction over any practitioner in contravention of this provision. The idea is to enable patients to refer to the National Specialist Register to check the credentials of a specialist. It is believed that bogus practitioners involved in non-evidence based medicine can be weeded out under this new system.
- Effective from 1 January 2019, a fully registered medical practitioner with an intention to practise in Malaysia must apply to the MMC for an annual practicing certificate with, at the very least, evidence of sufficient continuing professional development points and Professional Indemnity Cover attached. Payment is required for the application.
The Medical (Amendment) Act 2012 and Medical Regulations 2017 may be found here.
3. Medical Devices: Deadline For Submitting Applications for Registration
The Medical Device Authority (MDA) has recently informed applicants that all pending applications in the MDA's online system, MedC@st, must be completed by 31 October 2017, failing which the application will be rejected and the device will not be registered.
As a recap, the MDA had granted a grace period of two years from 1 July 2013 for establishments who had previously imported, exported or placed medical devices in the market to continue to do so pending the approval of the registration. On 1 July 2015, the Minister granted a further extension of the grace period to 30 June 2016.