Day 12 - Compliance Department and about KOLs

Just a quick overview of the compliance department. Compliance here is a specialized area of staffs which worked a few years in MSD and has a comprehensive experience of how the company operates. They are the ones who set the procedures on how to track the processes that each department are involved in, from little things like knowing whether a budget to sponsor doctors are actually overspent, to big things like breaching the grant of authority (GOA). GOA is the maximum amount of spendings that can be approved for a certain ranking staff, the amount of grant that you can authorize.

Compliance also enforces the company values by training new staffs on these values and even build case studies on them. If MSD outsources to a 3rd party company for any kind of service, their staffs also need to be made aware of these values, and that's where compliance come in to make sure these values are adhered to. This is because, should the 3rd party company break any law, MSD as the hiring company will take responsibility as well. Companies like Zuellig Pharma are one of the examples as an outsourced distributor.

Basically the compliance department do not deal with review of promotional materials as that will be scrutinized under the medical department. However, the Standard Operating Procedures (SOPs) in which these reviews are conducted, as well as how sales calls are conducted by the product specialists, are thoroughly enforced by the compliance team as well. The compliance department carries out risk assessment on every type of business risk to see whether is the risk very frequent, or how big is the impact, and hence puts priority on each kind of risk. Then, they plan for the year to tackle each issue to further strengthen the company's structure year after year.

After lunch, Michelle was our mentor for the session on KOLs. As MSD also deals with many important hospitals, with each hospital having up to around 80 doctors, a few key account managers are designated to these hospitals. Their job is to handle that very hospital that they are assigned to. However, many problem arises with hospitals as each have their own policy on prescribing and treatment, furthermore there is a "blue book" formulary which contains the list of drugs the hospital is authorized to prescribe.  Some of the products are not in the blue book, hence lots of approvals are needed for new unregistered drugs to penetrate into the Malaysia hospital markets.

Sometimes, key account managers also have to engage with KOLs from their assigned hospitals. When inviting a KOL to help give a talk in CME events, it not only involves making appointment, booking the venue and sponsoring the doctors, but you also have to convince the doctor why the need to attend the event and what are the intended outcomes. Because many pharma companies sought after these KOLs every year, so it is an important job which needs much cooperation from the sales & marketing department as well as the medical affairs department.

Just to share with you, before a tender is raised to the government for lets say, HPV vaccine, a form called Lampiran Q needs to be filled, which states all the necessary details and T&C which needs to be adhered to before submission.