Lancet Report On Essential Medicines Takes Aim At Access, Affordability

A much-anticipated report on progress in global access to essential medicines released today has found that change is needed to the system of paying for research and development, including moving beyond sole reliance on patents to cover R&D costs. It calls for a global R&D policy framework, a possible patent pool for essential medicines, addresses financing issues, and claims to have developed a new cost model. Meanwhile, comments ranged from two ministers from the Netherlands said the system is broken while a leading industry executive criticised it for questioning the patent system.

A UK-based group referred to as the Lancet Commission has published a report examining progress made, and remaining challenges for access to essential medicines. The report comes some 30 years after the 1985 Nairobi Conference on the Rational Use of Drugs. The Commission came up with a series of recommendations for global medicines policies for the next two decades to increase access to essential medicines for universal health coverage.

The report published overnight includes 22 recommendations addressed mostly to governments but also health authorities, and other stakeholders such as the pharmaceutical industry.

The World Health Organization, governments, the pharmaceutical industry, and civil society are expected to attend the launch of the report today. Details on the launch event are here [pdf].

Co-chairs of the report presented some recommendations of the Commission yesterday during a press briefing. These were Veronika Wirtz, associate professor at Boston University School of Public Health, Hans Hogerzeil, professor at the University of Groningen, the Netherlands, and Andy Gray from the University of KwaZulu-Natal, Durban, South Africa.

Delinking Price from R&D Cost

Something new to the debate from the report is the costing model created by the Commission, they said. The Commission found from its new costing model that for US$1-2 per month, every person in low income and middle-income countries can have access to about 200 essential medicines.

They also said the report takes the view that an innovation system for the world only based on patents as a way to recoup the cost of research and development will never lead to the development of missing essential medicines that are needed. They further said that the de-linkage of R&D costs from the price of medicines should be explored, as well as prize funds, which provide incentives for innovation through rewards.

Intellectual property is one of the access barriers to essential medicines, but there are many others, they said.

According to the report, the Commission looked at access to medicines covering all aspects of financing, affordability, quality, use, and essential innovation. The recommendations provided are aimed at actors in the health system, such as governments, civil society, national health institutions, national medical regulatory agencies, and the pharmaceutical industry.

Financing of Essential Medicines

Financing of essential medicines featured prominently in the recommendations too. At the briefing, Gray presented Commission recommendations on this area.

The Commission recommended that governments provide adequate financing to ensure inclusion of essential medicines in the benefit packages provided by the public sector and all health insurance schemes; and that they implement policies that reduce the amount of out-of-pocket spending on medicines.

The Commission also called on the international community to fulfil its human rights obligations to support governments in financing a basic package of essential medicines for all, if they are unable to do so domestically.

On increasing the affordability of medicines, the Commission recommended that governments and health systems create and maintain information systems for routing monitoring of data on the affordability of essential medicines, as well as price and availability, in the public and private sectors. Governments are also called on to implement a set of policies to achieve affordable prices for essential medicines.

Missing Essential Medicines, Quality Issues

Hogerzeil underlined an issue of the quality of essential medicines, with over a quarter of malaria medicines being substandard in several African countries, for example, and said one of the core recommendations of the Commission is that harmonisation is needed at the international level and regional collaboration. National agencies should focus on enforcement, he added.

He also said the current R&D efforts are mostly focusing on modifying existing medicine for little therapeutic additional value, and on developing medicines which can be sold at high prices in high income countries.

The Commission recommended that governments and WHO take international public leadership for priority settings for essentials R&D taking into account public health needs of low and middle-income countries (LMICs); and that the international community create a general essential medicines patent pool. They also called for the pharmaceutical industry to better align its R&D priority setting with global health needs, and develop access strategies to make medically important innovations available, the report said.

Some important unmet public health needs include heat-stable insulin, shorter treatments for latent and active tuberculosis, single-day treatments of malaria, treatments for multidrug-resistant tuberculosis, as well as essential diagnostics, the Commission found. The report also underlines “the alarming crisis in antimicrobial development,” in which “a market-driven R&D system will not invest in new life-saving antimicrobials if their use will have to be rationed from the start to prevent resistance.”

The report also found that some essential medicines have been abandoned and are no longer produced in volumes that meet global demand, for lack of profitability, such as snake anti-venoms.

The Commission said that an international agreement should be sought on a global list of missing essential medicines with due regard of the needs of LMICs. “R&D on the listed diseases should be supported by dedicated funds, and the list should be regularly updated,” it said.

The Commission recommended that governments lead the process towards a global R&D policy framework and agreements, which include new financing mechanisms to ensure that missing essential medicines are developed and made affordable. Such mechanisms, the report said, should be based on transparent estimates on the real cost of R&D. Those mechanisms could include “a pooled fund for global health R&D, prize funds, targeted research partnerships and advance market agreements, and licensing of related patents, leading to an increasing number of new priority products with an affordable price which is delinked from R&D costs.” The pooled fund could be hosted by the Medicines Patent Pool, the authors said.

Wirtz said the Commission also addressed ways to promote the quality use of medicines and prevent inadequate use. The Commission identified four types of inadequate use, she said: overuse, misuse, underuse, and inappropriate use.

The Commission recommended that governments and the main public or private payers establish independent pharmaceutical analytics units to focus on generating information to promote quality use, the report said.

Wirtz also said that an accountability framework is needed to measures progress accomplished on the 22 recommendations formulated by the Commission. Some 24 core indicators are suggested by the Commission, she said. Example of indicators, she said, are the percentage of pharma expenditure compared to total household expenditures, or how much the MPP is actually serving to make medicines more affordable and available.

IP Contentious, Lancet Says; System Broken, Dutch Officials Find

According to Pamela Das and Richard Horton from The Lancet, in featured comments in the report, “one of the most contentious policy issues is intellectual property.”

“With strategic patenting in key producing countries, a few patents can prevent access to low-cost generic medicines and necessary combination products for millions of people living with life-threatening diseases,” they said.

Most new essential medicines are under patents, and will be for many years to come, they said.

“Although the number and proportion of essential medicines that are patent-protected may seem low, the overall impact can be huge,” the report said, adding that high prices for cancer medicines and hepatitis C treatments affect all countries.

No real progress can be achieved “without acknowledging that the current patent-based business model and the way we apply international patent rules need to change.” “The system is broken,” said Lilianne Ploumen from the Ministry of Foreign Affairs of the Netherlands, and Edith Schippers. Ministry of Health, Welfare and Sport of the Netherlands, in comments provided in the report.

Patent and intellectual property exclusivities are the only cornerstone of the current model, and companies can ask the price they like, the report said. “This will no longer do,” said the officials, calling for alternative business models.

The Commission in the report supported proposals to progressively delink the cost of R&D for priority medicines from the price of the products, and to develop new ways of sharing the cost burden of innovation internationally.

IP Not an Issue, GSK Says

Andrew Witty, GlaxoSmithKline, in a comment to the Commission included in the report, said the private sector was not represented in the Lancet Commission, and it was a missed opportunity. echoing what he said about the recently released UN High Level Panel. He said the supports the Commission’s findings that regulatory processes need to be stringent but streamlined, harmonised and avoid duplication. However, he disagreed on the Commission’s finding that “the present system for developing medicines is in crisis or that radical reform is necessary.”

He said the present intellectual property-based system “has delivered innovation and health improvements to a quite staggering degree.” There is room for improvement, he acknowledged, and new models and mechanisms for developing and delivering medicines need to be scaled up.

He also disagreed on the Commission’s view that intellectual property acts as a barrier to access. IP has no role in the lack of access to unpatented medicines on the WHO Essential Medicines List, he said, “so solutions based on intellectual property will not help.”

Background

In setting out the report, the Lancet Commission identified five areas as crucial to ensure access to medicines for the year 2030 (a UN target date for global progress): paying for a basket of essential medicines, making essential medicines affordable, assuring the quality and safety of medicines, promoting quality use of medicines, and developing missing essential medicines.

The three co-chairs told Intellectual Property Watch after the briefing that The Lancet medical journal provides a key resource based on scientific findings. The journal has been known to push positions in public health policy.

The co-chairs said the Commission goes further than the recently released United Nations High Level Panel on Access to Medicines, and looks at innovation in a holistic manner. One of the most important statements of the Commission’s report is that the problem of essential medicines is really global, and not merely a problem for developing countries, they told Intellectual Property Watch.

 

Image Credits: Boston University