De-linkage is a proposed model for development of new

pharmaceutical drug Medication (also called medicament, medicine, pharmaceutical drug, medicinal product, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy ( pharmacotherapy) is an important part of the ...

s where "de-link" refers to isolating the profitability of a drug from its volume of sales. In the current

business model A business model describes how a Company, business organization creates, delivers, and captures value creation, value,''Business Model Generation'', Alexander Osterwalder, Yves Pigneur, Alan Smith, and 470 practitioners from 45 countries, self-pub ...

, the

pharmaceutical industry The pharmaceutical industry is a medical industry that discovers, develops, produces, and markets pharmaceutical goods such as medications and medical devices. Medications are then administered to (or self-administered by) patients for curing ...

relies on the pricing and sales of its products to generate profits and to finance

research and development Research and development (R&D or R+D), known in some countries as OKB, experiment and design, is the set of innovative activities undertaken by corporations or governments in developing new services or products. R&D constitutes the first stage ...

of new drugs. This ability is dependent on the

monopoly A monopoly (from Greek language, Greek and ) is a market in which one person or company is the only supplier of a particular good or service. A monopoly is characterized by a lack of economic Competition (economics), competition to produce ...

granted through

patent A patent is a type of intellectual property that gives its owner the legal right to exclude others from making, using, or selling an invention for a limited period of time in exchange for publishing an sufficiency of disclosure, enabling discl ...

s. In the de-linkage model, other means (such as lump sums) would be used to reward companies for research and development in exchange for restricting the price charged for the product. This would allow the product to be sold at prices closer to production costs which would ensure better access, particularly for poor people and those who pay for their own treatment.

History

De-linkage was first promoted by

civil society Civil society can be understood as the "third sector" of society, distinct from government and business, and including the family and the private sphere.research and development Research and development (R&D or R+D), known in some countries as OKB, experiment and design, is the set of innovative activities undertaken by corporations or governments in developing new services or products. R&D constitutes the first stage ...

than the patent-based system, alongside possible ways to implement financing flexibilities internationally. This was opposed by the industry as it was seen as an attack on the patent system on which the current business model depended. It was also questioned because it involved governments deciding how R&D should be rewarded instead of the

free market In economics, a free market is an economic market (economics), system in which the prices of goods and services are determined by supply and demand expressed by sellers and buyers. Such markets, as modeled, operate without the intervention of ...

. An early effort to implement delinkage of R&D incentives from drug prices was the Medical Innovation Prize Fund legislation first introduced in the House of Representatives by Bernie Sanders in 2005, and subsequently revised and reintroduced several times. Several national governments support measures to move toward delinkage.

De-linkage and development of new antibiotics

Until resistance has emerged against a previous generation of antibiotic, commercial return for any given new drug is uncertain. Therefore, the de-linkage model may be preferable in the context of developing new antibiotics and the fight against resistance where new

antibiotics An antibiotic is a type of antimicrobial substance active against bacteria. It is the most important type of antibacterial agent for fighting pathogenic bacteria, bacterial infections, and antibiotic medications are widely used in the therapy ...

initially are unlikely to sell in large quantities because they should be reserved for use only when all other options have been exhausted. De-linkage also removes the incentive for the industry to boost sales that may encourage overuse that accelerate the development of

antibiotic resistance Antimicrobial resistance (AMR or AR) occurs when microbes evolve mechanisms that protect them from antimicrobials, which are drugs used to treat infections. This resistance affects all classes of microbes, including bacteria (antibiotic resis ...

References

Charles Clift.
De-linkage: A Way Forward for Antimicrobial Drugs
{{Webarchive, url=https://web.archive.org/web/20160604112819/https://www.chathamhouse.org/expert/comment/17659 , date=2016-06-04 ", chathamhouse.org, 14 May 2015. Retrieved 7 May 2016. Jim O’Neill.
Securing New Drugs for Future Generations: The Pipeline of Antibiotics — The Review on Antimicrobial Resistance
p2, amr-review.org, May 2015. Retrieved 7 May 2016. Pharmaceuticals policy Drug development Patent law Monopoly (economics) Antimicrobial resistance Drug pricing

History

De-linkage and development of new antibiotics

See also

References