Lancet Commission on Essential Medicines Policies publishes 74 page report, endorses delinkage of R&D costs from drug prices

Today The Lancet Commission on Essential Medicines Policies published the 74 page report on "Essential Medicines for Universal Health Coverage." A copy is available here.

The report is rich in data, analysis and recommendations. The report endorses the delinking of R&D costs from drug prices:

Delinking R&D costs from the price of medicines

The concept of delinking costs from prices is based on the premise that costs and risks associated with R&D should be rewarded, and incentives for R&D provided by means other than through the price of the product.436 If the R&D cost of new medicines did not have to be recouped through high prices, those medicines would be free of market exclusivity and could be made more widely available and more aff ordably priced through better competition. The Commission supports 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. Page 54

The Lancet report is rich with conclusions and recommendations on many topics, including five recommendations relating to "stronger public policies on R&D". These cover such topics as the implementation of the WHO Global Health R&D observatory, development of a list of "missing medicines," transparency of R&D costs, transformation of the MPP to a general essential medicines patent pool (EMPP), rejection of TRIPS plus measures in trade agreements, the use of compulsory licensing and other areas of policy space in international intellectual property norms to expand access to medicines, the engagement at the WHO to negotiate "a global R&D policy framework" and agreements to fund R&D, including new financing mechanisms, and policies to delink R&D costs from product prices.

Recommendations

The Commission’s analysis shows that challenges of access to new essential medicines are directly associated to the failure of the current R&D system to develop much needed new medicines. The Commission makes the following recommendations for stronger public policies on R&D, including at the international level.

1 Governments and WHO must take international public leadership for priority setting for essential R&D, with due regard for the public health needs of LMICs. This should include developing a list of missing essential medicines, within the context of the WHO Global Health R&D observatory and in close connection with the WHO Model List of Essential Medicines. The WHO mechanism to identify missing essential medicines should be further developed, with the involvement of all relevant stakeholders.

2 Governments must 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 should be based on transparent estimates of the real cost of R&D; they might 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 (known as progressive delinking).

3 The international community must create a general EMPP. Such a pool could be hosted and managed by the current MPP. Companies should license their patents related to essential medicines to the EMPP under a set of conditions. Patents of medicines developed under the new research agreement or any other new financing mechanism could also be licensed through the EMPP. The EMPP should use a tiered royalty system to remunerate the patent holder and to contribute to R&D expenditure.

4 Governments and national stakeholders must develop and implement comprehensive national action plans to guarantee equitable access to new essential medicines, including open knowledge innovation, fair licensing practices, support for a patent pool for essential medicines, full use of TRIPS flexibilities when needed, and rejecting TRIPS-plus provisions.

5 The pharmaceutical industry must better align its R&D priority setting with global health needs, and develop access strategies to make medically important innovations available to all in need. To this end the industry could determine a certain percentage of its profits to reinvest in R&D for medicines that are not commercially attractive, but are deemed essential from a public health perspective. Equitable access strategies should include broad licensing of patents and technology transfer to enable generic medicines production; and equitable pricing mechanisms. The policies and practices of pharmaceutical companies should be independently assessed by international mechanisms, such as the ATM Index.

Pages 56-57.

KEI comment on the report of the Lancet Commission on Essential Medicines Policies:

The 22 members of the Lancet Commission on Essential Medicines Policies have delivered a report rich in practical suggestions for expanding access to treatments, and creating systems to ensure that there is robust financing for R&D to address pressing health needs. The timing of this report could not be better. The United State government and the WHO will have new leadership in 2017, and this report can and should shape their agendas. The Commission's impressive and knowledgeable members have successfully blended the best inspirational values regarding fairness with the concrete measures to achieve real results.

The Lancet Commission report provide more support for reforms that were also addressed by the UN Secretary General High Level Panel and Access to Medicines, including most importantly, to progressively delink R&D costs from drug prices, both to improve the efficiency and efficacy of the system of incentives for R&D, and to make access more fair.

James Love, Knowledge Ecology International