Elsevier

The Lancet

Volume 376, Issue 9744, 11–17 September 2010, Pages 922-927
The Lancet

Health Policy
Introduction of European priority review vouchers to encourage development of new medicines for neglected diseases

https://doi.org/10.1016/S0140-6736(10)60669-1Get rights and content

Summary

Every year 1 billion people worldwide are affected by traditionally neglected diseases, such as malaria, tuberculosis, leishmaniasis, and lymphatic filariasis, which impose tremendous public health burdens. Governments, foundations, and drug manufacturers have, however, started to support development of new treatments. European Union Member States have been leaders in implementing so-called push mechanisms (payment for drug development) and pull funding (reward for output), such as the advance market commitment, which creates a market for vaccines by guaranteeing prices. We propose an additional step that could be taken to encourage development of medicines for neglected diseases. A priority review voucher scheme, as is already in place in the USA, would reward a manufacturer that developed a new medicine for neglected diseases with a voucher that could be redeemed for priority review of a future medicine, probably a potential blockbuster drug. Unlike the US system a European voucher would also accelerate pricing and reimbursement decisions. This scheme would be likely to provide substantial benefits to voucher holders, society, and public health organisations.

Introduction

Diseases such as malaria, tuberculosis, leishmaniasis, and lymphatic filariasis impose substantial health burdens but are widely neglected because there is little incentive in the private market to develop new treatments.1 Most of the 1 billion people affected by neglected diseases live in low-income countries.2 Improvement of health conditions in developing countries is among the UN Millennium Development Goals.

Governments and foundations have recognised the dearth of private-sector incentives and have provided so-called push funds for research and development (funding for drug development)3 and pull mechanisms (rewards for output) to reward successful development.4 One important pull mechanism is the advance market commitment, which creates a market for vaccines by guaranteeing prices.5 Through such efforts, governments of the European Union (EU) Member States have been leaders in encouraging development of treatments for neglected diseases. Here we propose a new incentive mechanism for the EU.

Section snippets

Priority review vouchers

The priority review voucher scheme is a market-driven incentive that rewards developers of new medicines for a neglected disease. The scheme is already available in the USA, with decisions being made by the Food and Drug Administration (FDA). It was proposed by Duke University faculty members (DBR, Henry Grabowski, and Jeffrey Moe) in 2006,6 became law in 2007, and the first voucher was awarded to Novartis in 2009 after FDA approval of Coartem (artemether and lumefantrine) for the treatment of

Value of accelerated assessment

Manufacturers highly value accelerated assessment but it is rare. For instance, in 2006 manufacturers filed 13 requests for accelerated assessment at EMA but only four were granted access to the accelerated system, and two of these four were later reverted to standard procedure.19 Manufacturers desire fast decisions because early entry brings forward availability in relation to competitors' drugs, enables earlier sales, and lengthens the effective patent-protected time on the market (figure).8

Alternative voucher scheme models

We propose that priority review vouchers be applied to branded medicines, but they could be extended to generic products, including follow-on biologics. As another alternative, rather than use the priority review voucher as a pull mechanism, vouchers could be auctioned and the proceeds used to fund push mechanisms.21 An advantage of auctioning and push funding is that uncertainty in outcomes and waiting times could be diminished for the drug developer. A disadvantage, however, is that the

Limitations

The proposed EU voucher scheme has limitations similar to those in the US system.6, 8, 22, 23, 24 First, the value of the voucher might be too generous if it rewards research that would be done anyway, but this feature is seen with other incentives, such as rewarding charitable donations with tax deductions even though some of the donations would have been made anyway. Policy makers could consider, among other things, limiting voucher eligibility to molecules that had not previously been

Conclusion

European governments have made substantial contributions to research and development of medicines for orphan and neglected diseases. The introduction of a priority review voucher scheme in the EU similar to that in the USA would be a useful additional contribution. Like the US version, a European voucher would accelerate regulatory decisions for new drugs. Unlike the US version, a European voucher would also accelerate pricing and reimbursement decisions. The use of similar systems in the two

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