Improved access | The Pharmaceutical Accountability Foundation

Solution #2: Improved Access

There are several ways to bring down prices and improve access to medicines. Strategies can include encouraging competition by breaking the hold of a monopoly, limiting the capacity of a monopoly holder to set sky-high prices through control or reference mechanisms, or taking solidarity action on rare or hard-to-treat diseases.

When high prices are due to issues outside of monopolies, there are other actions that can be taken by both governments and medicines developers to improve access.

Regulatory challenges are often quite specific to the medicine or the malady in question. But some individual solutions are worth exploring as ways to overcome these issues.

Solution #1: Better Innovation Models

Solution #3: Strong Enabling Environment

Improved access: Solution contents

There are several solutions that can act to improve knowledge, intellectual property and technology sharing, lower prices, and improve access to essential medicines. Click on the top level links below or scroll down to explore more.

Avoiding or working around monopolies

Patent pooling
Compulsory licensing
Voluntary licensing
Other flexibilities

Avoiding high prices

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

Avoiding other barriers

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Related Issues: Access challenges

Medicinal products are not always accessible or affordable for those that need them. There are many reasons for access problems, including monopolies that limit competition, high prices, weak health infrastructure or regulatory barriers.

See issues

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Avoiding or working around monopolies

Patent pooling

*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.

Compulsory licensing

*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.

Voluntary licensing

*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).

Other flexibilities

*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.

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Avoiding high prices

When high prices are due to issues outside of monopolies, there are other actions that can be taken by both governments and medicines developers to improve access. These include:

Delinkage

“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.

Good company principles

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.

Fair pricing

*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.