De-linkage is a proposed model for development of new

pharmaceutical drug A medication (also called medicament, medicine, pharmaceutical drug, 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 medical field and re ...

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 an organization creates, delivers, and captures value,''Business Model Generation'', Alexander Osterwalder, Yves Pigneur, Alan Smith, and 470 practitioners from 45 countries, self-published, 2010 in economic, social, ...

, the

pharmaceutical industry The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients (or self-administered), with the aim to cure them, vaccinate them, or alleviate symptoms. ...

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 Europe as research and technological development (RTD), is the set of innovative activities undertaken by corporations or governments in developing new services or products, and improving existi ...

of new drugs. This ability is dependent on the

monopoly A monopoly (from Greek language, Greek el, μόνος, mónos, single, alone, label=none and el, πωλεῖν, pōleîn, to sell, label=none), as described by Irving Fisher, is a market with the "absence of competition", creating a situati ...

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 enabling disclosure of the invention."A p ...

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 Europe as research and technological development (RTD), is the set of innovative activities undertaken by corporations or governments in developing new services or products, and improving existi ...

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 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 government or any o ...

. 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.{{cn, date=August 2018

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 bacterial infections, and antibiotic medications are widely used in the treatment and prevention o ...

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) occurs when microbes evolve mechanisms that protect them from the effects of antimicrobials. All classes of microbes can evolve resistance. Fungi evolve antifungal resistance. Viruses evolve antiviral resistance. ...

References

Charles Clift.
De-linkage: A Way Forward for Antimicrobial Drugs
, 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. Pharmaceutical industry Research and development Patent law Monopoly (economics) Antimicrobial resistance

History

De-linkage and development of new antibiotics

See also

References