Good Pharmaceutical Trading Practices (GPTP) for Private Sector
Good Pharmaceutical Trading Practices (GPTP) for Private Sector is a guideline initiated by Pharmacy Service Department, Ministry of Health Malaysia. GPTP is seen to be governing the Trade Matters under the Good Governance of Medicines (GGM), and also a guide to be followed to ensure the nation to achieve its objectives of National Medicine Policy (Dunas).
MCPG has been actively involved all dialogues with the Pharmacy Service Department from the beginning and glad that it was finally finalized and endorsed by the government in 2015. Not long from that, an official reminder letter from the department has also been circulated out to all stakeholders to ensure that this guideline to be followed. This GPTP Unit under MCPG is formed with the objectives to follow up the practice of GPTP, as well as to liaise with all stakeholders for any amendment from time to time to ensure the guideline remain relevant with the development of our healthcare system.
Scope of products
GPTP applies for medicines in Group B and Group C as stated in Poison Act 1952.
* Group B: Prescription Only Medicine (POM).
* Group C: Pharmacist Only Medicinal Product (POMP).
* Psychotropic substances, dangerous drugs and pseudoephedrine are excluded from this guideline.
GPTP covers all licensed pharmaceutical distribution channels including but not limited to pharmacies, clinics, hospitals and wholesalers.
1. Standard price and bonus scheme to all channels and healthcare providers.
• All pharmaceutical companies shall extend the same bonus scheme to all distributing channels.
• Reasonable bonus scheme is allowed.
• There should not be any inducement for purchase with extra gifts and benefits.
• Accessibility of product shall not be impeded with trading terms such as additional charges, listing fees and etc.
2. Provision of an official wholesale price list and formal announcement on price revision or any change of trading terms from the suppliers
• Formal notification from the company before any price revision should be sent to all relevant distributing channels and MOH at least 1 month before the execution of new price.
• Suppliers shall provide an official wholesale price list to MOH once a year.
3. There should not be any market exclusivity for a product to any channel unless advised or directed by MOH.
• All products and their stock keeping unit (SKU) should be made available to all distributing channels.
4. Promotion of products and services responsibly within the code of conduct/ practices.
• All associations and guilds shall develop their own code of conduct/ practices in line with the MOH’s guideline on good governance in medicine (has not developed yet).
5. Appropriate system of control and accountability of sample provided to healthcare professional shall be established.
• Samples are not meant to be sold and resell.
• Samples are only for newly launched medicines less than 2 years in market, unless justified.
• Sample distribution by medical representatives shall be discouraged.
6. The industry shall have competent and ethical medical representatives.
• Industry association shall assist in developing and implementing the updated training curriculum.
i. Licensed pharmaceutical distribution channels: Any registered distribution channels with appropriate license issued by MOH related to their business.
ii. Reasonable bonus: 30% differences (MCPG has kept this option open after being briefed that the practice is not feasible as it may increase the price of the medicines)
iii. Newly launched medicinal product: New product (new chemical entity and generic) marketed from the first date of commercial sales.
iv. Medical representatives: Qualified and trained personnel who provides insight scientific knowledge and/ or sales of a product.
v. Unless advised or directed by MOH:
• it is case to case basis especially for highly specialized product or treatment e.g. HIV case.
• packaging for special requirement.
• to safeguard public health.
Reporting Supply Chains for Not Adhering to GPTP to MCPG
Members who encountered or has the evidence of any supply chain under the scope of GPTP for not adhering to the GPTP are encouraged to report the matter and provide the evidence and event details to MCPG Council through this webpage.
Upon receiving sufficient details of the report, the complainant will receive a Case ID for follow up.
MCPG shall first initial the mitigation process with the said supply chains to ensure they take the corrective action to adhere the GPTP with official letter from them. All correspondence in this stage will be made known to relevant officers from Ministry of Health, as well supply chains’ overseas HQ.
ii. Reporting to Malaysia Pharmacy Council
Upon failing to get any satisfactory action plan or response from the said supply chains in 7-business day, or in the period of time agreed by the council members, the case shall be escalated to the attention of the Malaysia Pharmacy Council.
iii. Reporting to MyCC, Medias and International Bodies
Upon failing to get any satisfactory action plan or response from the Malaysia Pharmacy Council, in the period of time agreed by the council members, MCPG may decide to report to Malaysia Competition Commission, MyCC, liaise with medias or respective international bodies. Council members may decide to escalate the complaints to the Director General of Health or Prime Minister’s Department depends on the severity of the non-compliance of GPTP.