Public-private partnerships
Joint development of (orphan) drugs by doctors/researchers within the academy and industry is one way to make drugs for rare diseases more available to patients.
To hit target, a public-private partnership (PPP) requires contributions from both sides. The academic contributes knowledge and public investment to get to a product faster and keep costs down. A company brings in a lot of value, e.g. additional funding for development and registration, expertise in economic feasibility, reimbursement and production according to laws and regulations, and has the distribution channels.
When companies invest, it is reasonable that a predetermined profit margin can be set in return, to compensate for the risk taken. It is crucial that this is done transparently. After all, socially responsible pricing is necessary for innovations to actually reach patients and remain affordable.
Socially responsible framework for PPPs
Sustainable, productive and social collaboration focuses on three elements, which include making data and knowledge available, fair pricing, and acting without unnecessary delays. This framework has been developed through literature, practical examples and own experiences. The list of 11 recommendations is an excellent checklist for early discussions between cooperation partners.
| Domain | Condition |
| Data ownership & evidence generation | 1. Data and other knowledge will be available to all stakeholders in compliance with GDPR regulations and FAIR data principles. |
| Socially responsible pricing | 2. Investment and price structure are transparent. |
| 3. Pricing is based on actual costs plus a reasonable profit margin. | |
| 4. Price adjustments are made after sufficient return of investments. | |
| 5. Public revenues will benefit a revolving fund for new projects. | |
| 6. Clinical trials in academic centres will be conducted at cost. | |
| 7. Marketing activities will be kept to a minimum. | |
| 8. Risks will be shared. | |
| Fast access | 9. All parties commit to the goal of bringing the product to patients. |
| 10. Termination or pausing of development is not allowed when there is sufficient evidence of patient benefit and a positive business case. | |
| 11. Inventions will not be sold to third parties without the consent of all stakeholders. If all stakeholders give consent, sale or out-licensing will only take place under the same socially responsible conditions. |
