These days, compounding of medicinal products is being presented as a way to reduce the cost of medicines. In the media, many pharmacies have expressed their intention to (start) compound(ing) medicinal products. However, the CDCA compounding hospital pharmacy in Amsterdam has been warned by the IGJ to stop compounding due to infringement of the Dutch Medicines Act. A recall at patient level was performed.
Nevertheless, the hospital pharmacy disclosed to continue compounding more (and other) medicinal products to “allow quicker and cheaper access to medicinal products for patients”.
Under what conditions is this allowed under the regulatory compounding exemption? What should be considered “small scale”? How if it concerns patented medicinal products? Under what conditions is this allowed under the patent law compounding exemption?
Are compounded products and authorized products equally safe and effective? How about the product liability for the compounding pharmacist?
Simultaneously, the Minister of Health is looking into compulsory patent licensing and is setting up a Commission Compulsory Licensing.
This seminar will provide more clarity on compounding and compulsory licensing and will provide you with hands-on advice.