Farma ter Verantwoording

Solution #2: Improved Access

Er zijn verschillende manieren om de prijzen te verlagen en de toegang tot medicijnen te verbeteren. Strategieën kunnen bestaan uit het aanmoedigen van concurrentie door het breken van een monopolie, het beperken van de capaciteit van een monopoliehouder om torenhoge prijzen vast te stellen door middel van controle- of referentiemechanismen, of het nemen van solidariteitsacties voor zeldzame of moeilijk te behandelen ziekten.

Wanneer hoge prijzen te wijten zijn aan problemen buiten monopolies, zijn er andere maatregelen die kunnen worden genomen door zowel overheden als geneesmiddelenontwikkelaars om de toegang te verbeteren.

Uitdagingen op het gebied van regelgeving zijn vaak vrij specifiek voor het geneesmiddel of de ziekte in kwestie. Maar sommige individuele oplossingen zijn het onderzoeken waard als manieren om deze problemen op te lossen.

Verbeterde toegang: inhoud van de oplossing

Er zijn verschillende oplossingen die kunnen werken om het delen van kennis, intellectueel eigendom en technologie te verbeteren, prijzen te verlagen en de toegang tot essentiële medicijnen te verbeteren. Klik op de links op het hoogste niveau hieronder of scrol omlaag om meer te ontdekken.

  • Patent pooling
  • Compulsory licensing
  • Voluntary licensing
  • Other flexibilities
  • Delinkage
  • Good company principles
  • Fair pricing
  • External reference pricing
  • Price-volume agreements
  • Joint procurement
  • Solidarity in health insurance for rare diseases
  • Buyers' clubs
  • Individual importation
  • Price control

Gerelateerde problemen: Toegangsuitdagingen

Geneesmiddelen zijn niet altijd toegankelijk of betaalbaar voor degenen die ze nodig hebben. Er zijn veel redenen voor toegangsproblemen, waaronder monopolies die de concurrentie beperken, hoge prijzen, zwakke gezondheidsinfrastructuur of regelgevende belemmeringen.

Avoiding or working around monopolies

*More information on this solution is coming soon. Subscribe to our newsletter to be notified when it is updated. As a subset of responsible licensing, the use of patent pools can be a powerful tool to increase access to patented medications. Because many individual medications can have layers of patent protection, owned by different actors, the cost of licensing them for generic production can be high: requiring multiple negotiations and multiple contracts. Patent pools can fix this by acting as a single source where patents related to a particular medication, a particular treatment regimen, or a particular disease area can be gathered in one location for ease of out-licensing to generic producers. The major example of this is the Medicines Patent Pool, a United Nations-backed body that aims to increase access to affordable medicines in low- and middle-income countries through patent licensing. It has focused on HIV, hepatitis C, and tuberculosis and is being looked at as a possible conduit for Covid-19 technologies. A second World Health Organization-backed initiative launched in May 2020, the Covid-19 Technology Access Pool (C-TAP) also aims to be a one-stop area for technology sharing related to fighting the Covid-19 pandemic.
*More information on this solution is coming soon. Subscribe to our newsletter to be notified when it is updated. Governments have the right to decide that the public need for access to a patented product outweighs the rights of the patent holder to maintain their monopoly. Under the World Trade Organization’s (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, WTO members are allowed to decide both when and why to issue a compulsory licence. When a government issues a compulsory license, it grants the right to other producers to make the needed product. Some royalty may be paid to the patent holder. WTO rules also allow for countries without the ability to manufacture medicines in their territory to request compulsory licences for export in countries with that manufacturing capacity.
*More information on this solution is coming soon. Subscribe to our newsletter to be notified when it is updated. Where patents exist, patent holders can engage in responsible licensing practices to facilitate access to needed technologies. Responsible licensing can include: the use of non-exclusive licences (allowing many manufacturers the right to produce a product, which facilitates competition); a requirement that use of a licensed technology in a product carries an obligation to set fair prices; an obligation for licensees to share improvements on a technology with other licensees; and transparency over terms and conditions within the licences. Responsible licensing can be particularly powerful if implemented by universities and other public research institutions, where a lot of the basic research – and therefore foundational technology – for many final medical products is conducted (see section on direct support, under Better Innovation Models, above).
*More information on this solution is coming soon. Subscribe to our newsletter to be notified when it is updated. There are other flexibilities contained within the World Trade Organization’s patent rules, including the right of Least Developed Countries (LDCs) to waive enforcement of intellectual property on medicines until 2033 or until they graduate from LDC status. Regional economic communities with a majority of LDCs have the rights to create economies of scale by banding together as a region to source a needed medicine.

Avoiding high prices

Wanneer hoge prijzen te wijten zijn aan problemen buiten monopolies, zijn er andere maatregelen die kunnen worden genomen door zowel overheden als geneesmiddelenontwikkelaars om de toegang te verbeteren. Deze omvatten:

“Delinkage” is the general concept that the cost of research and development should be unrelated to the eventual price of a potential medical product. How much it costs to develop a medicine is a matter of some disagreement, with pharmaceutical companies often claiming it costs $2.6 billion while non-profit drug development entity the Drugs for Neglected Diseases initiative has said it paid a fraction of that [$65-205 million] for a new chemical entity. But in any case, the high cost of research is the oft-cited reason for the high cost of medicines. The profit motive is also why there is systematic under-investment in medicines for which no significant market exists. Delinkage proposes to separate incentives for medical development from profits, allowing for a more public-health focused agenda. There are many ways to delink the price of a product from the cost of its development, including prize funds, direct financing and tax credits.
PAF keeps a record of good company principles in responding to the Covid-19 pandemic. Learn more about that here. *More information on this solution is coming soon. Subscribe to our newsletter to be notified when it is updated.
*More information on this solution is coming soon. Subscribe to our newsletter to be notified when it is updated. Effective and innovative medicines are kept out of reach for many patients worldwide due to high prices. (see Issues: Access Problems due to High Prices). A ‘fair price’ is envisioned as one which is ‘affordable to the buyer while covering the seller’s costs and providing a reasonable profit margin’. A fair price should align affordability for health systems with market incentives for pharmaceutical innovation. Defining a fair price in relation to a specific product requires transparency about the costs incurred in R&D, manufacturing and distribution of the medicine. Applying a fair pricing strategy is therefore inherently linked to this type of public disclosure. The WHO organises ‘Fair Pricing Forums’ to encourage dialogue between stakeholders about creating a fairer global pricing system for medicines.

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External Reference Pricing (ERP), also known as International Reference Pricing, occurs when a government uses pricing data from ‘reference countries’ to inform its own pricing regulation of the same drug. This policy aims to ensure that one country’s drug prices are not disproportionate when compared with foreign medicine prices.
Reference countries can be determined by income per capita, health system structure similarity, geographic proximity, etc.


ERP is widespread across the European Union, with 23 Member States implementing this policy tool. However, calculation methods vary wildly - there is yet no transnational coordination of ERP implementation methods.

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Buyer’s clubs have sprung up around certain diseases to bypass situations where a needed treatment (or often an affordable generic version of a needed treatment) is not available in a certain country. Examples of this abound in the early days of the HIV pandemic; many are now in use to access low-cost versions of Orkambi, a cystic fibrosis medicine, to access PreP, a prophylactic treatment for HIV, or to access affordable sofosbuvir to treat Hepatitis C Virus.

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Avoiding other barriers

*Meer informatie over deze oplossing volgt binnenkort. Abonneer u op onze nieuwsbrief om op de hoogte te worden gehouden wanneer deze is bijgewerkt.