NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

Is that a fact Jack? Or is it simply your understanding that companies supplying unlicensed medicines (specials) can’t make a profit? If it is a fact, can you post a link?

Yes they can charge cost but not profit at all from it. It’s modest direct costs only….

None of the regulations or guidance that I’ve read state this. In fact, I’ve read that there are no restrictions on pricing, and companies can charge a reasonable profit:

The Human Medicines Regulations 2012
UK Statutory Instruments 2012 No. 1916 PART 10 Exceptions Regulation 167

https://www.legislation.gov.uk/uksi/2012/1916/regulation/167/made


The supply of unlicensed medicinal products (“specials”)
MHRA Guidance Note 14

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/373505/The_supply_of_unlicensed_medicinal_products__specials_.pdf

UNLICENSED MEDICINAL PRODUCTS IN THE UK

CHARGING FOR SUPPLY
The 2012 Regulations do not place any restrictions on companies charging for the supply of unlicensed medicinal products, and historically there were no other restrictions on pricing or pharmacies’ ability to seek reimbursement for unlicensed medicinal products under the NHS.

However, concerns that some pharmacies were making excess margins on unlicensed medicinal products led to the introduction of a new Part VIII B of the Drug Tariff (see NHS: Electronic Drug Tariff: Arrangements for payment for Specials and Imported Unlicensed Medicines). As at August 2016 this set limits on prices of 250 high-cost, high-volume unlicensed medicinal products prescribed commonly and supplied on NHS prescription, using sales and volume data from suppliers (see NHS: Part VIIIB: August 2016).

https://www.arnoldporter.com/~/media/files/perspectives/publications/2017/02/unlicensed-medicinal-products-in-the-uk.pdf

Stripes: That's A Fact Jack