Joyce A. Tan & Partners LLC | View firm profile
Pharmaceutical companies that plan launches of prescription-only medicines need to be aware: there are regulatory matters in Singapore things which can interrupt your launch if they’re not sufficiently attended to.As you can see from my earlier article (https://www.linkedin.com/posts/joyce-a-tan-%26-partners_earned-media-legitimate-publicity-or-product-activity-7213730770949980160-16Gr?utm_source=share&utm_medium=member_desktop ), product promotion and advertisement of therapeutic product is regulated in Singapore and you should familiarize yourself with the key issues in doing so especially for new product launches. Here’s a brief write up on this – plus a checklist that might be essential whenever formulating plans and strategies around such product launches.
Our checklist is below. These are some of the questions that a pharmaceutical company should consider and helpful information to navigate the regulatory requirements. However, it is important to note that the reference to product in this article only relates to prescription only medicines. Different requirements may apply to other classification of health products.
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- Can I conduct pricing market research for new products which are still pending HSA approval and if so, is it compliant for my company to disclose the product name to the market research agency?
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- Are there any considerations in my engagement with healthcare professionals in the days leading to my product launch?
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- Can my company create any social media posts referring to the launch of the new product?
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- If so, are there any concerns if my employees interact with the posts?
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- If my company wish to create disease awareness campaigns or posts to create more awareness of the disease that is the subject ofthe new product, are there any time considerations prior to or post the launch that I should consider before creating the disease awareness campaign?
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- If my company were to support patient support program by assisting to bringing in the product early for early access treatment by certain patients, are there any considerations that I need to bear in mind in supporting such a request?
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- What happens after the product has been launched? Can the patient support program continue to run? This is especially so as we experience a rise in oncology drugs that are being introduced into Singapore and most of these oncology drugs have already been used in countries outside of Singapore.
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- If I wish to organize a product launch event are there any considerations I need to consider? Can I even organize such an event? What are the special considerations when organizing such product launch event?
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- Are releases to the press regarding information about the product and the product launch ever permissible and if so, how can it be done compliantly?
Key regulations and guidelines that you need to consider in relation to some of the questions raised above are Health Products (Advertisement of Specified Health Products) Regulations 2016 (and the corresponding Explanatory Guidance to the Health Products (Advertisement of Specified Health Products) Regulations 2016) as well as the Code of Conduct issued by the Singapore Pharmaceutical Industry Association (or SAPI). Please note that even though the code of conduct issued by SAPI is only applicable to member companies of SAPI, it is notable that in 2005, the Health Science Authority created a guideline on disease awareness campaign in consultation with SAPI. Accordingly, having an understanding of the Code can give you potential insights as to how regulators may look at such activities.