Past seminar

Compounding pharmacists – challenges for the (bio) pharmaceutical industry

When

Wednesday 17 April 2019

Where

Pakhuis de Zwijger
Piet Heinkade 179 (next to the Axon office)
1019HC Amsterdam

What time

Registration and coffee: 15:30

Start seminar: 16:00

Drinks and snacks: 18:30

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.


Speakers

Hanneke Later-Nijland

Attorney-at-law at Axon Lawyers, pharmacist by training, lecturer at Leiden University Medical Centre

Compounding: an overview of the legislation, case law and the current state of affairs

Andras Kupecz

Patent lawyer, patent attorney, biologist by training, founder and attorney-at-law

The compounding exemption under patent law and compulsory licensing

Peter Bertens

Senior Policy Advisor and Projectleader, Vereniging Innovatieve Geneesmiddelen

Vision of the Vereniging innovatieve geneesmiddelen on compounding and compulsory licensing

Panel discussion

The speakers will be joined by Sandra de Wild-Chardonnens of Netherlands Foreign Investment Agency (NFIA) for a panel discussion



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