Posts Tagged: "access to medicines"

When it comes to how to best increase access to medicines in l0w and middle-income countries (LMICs), compulsory licensing gets most of the attention. Academic articles, non-governmental organization (NGO) campaigns, conferences and United Nations (UN)-endorsed technical symposia assert it is the best approach. Certain World Trade Organization (WTO) members are pushing for COVID-19 treatments and diagnostics to be included in the waiver of intellectual property rights under the Agreement on Trade-Related Aspects of IP Rights (TRIPs waiver), which revolves around compulsory licensing. Brazil has recently amended its IP laws to make compulsory licensing easier. Despite its high political profile, compulsory licensing has rarely been used (mainly by a handful African countries in the mid 2000s to address the HIV pandemic). Even then, IP-respecting treatments available from global procurement bodies have proven cheaper. No country has yet seen the need for a compulsory license for a COVID vaccine.

The cost of medicines is on the agenda this week at the World Health Organization’s annual executive board meeting in Geneva. Nongovernmental organizations and certain middle-income countries argue that market-based drug development—reliant on intellectual property rights (IPRs) as its primary incentive—makes medicines too expensive. It fails, they say, to provide cures for those most in need but least able to pay. On the fringes of meetings such as the one happening this week, nongovernmental organizations talk excitedly about a new model for drug development, in which research and development (R&D) costs are “delinked” from the final prices of drugs. They join notables such as U.S. Senator Bernie Sanders and Nobel prize-winning economist Joseph Stiglitz. One of the main “delinkage” proposals is to replace the patent system with government-managed prizes.

Founded in 2006 by the governments of France, the United Kingdom and several others, and financed by a combination of a tax on airline tickets and government grants, Unitaid is one of the lesser known players in the crowded world of global health. Unitaid’s most distinctive contribution is its Medicines Patent Pool (MPP), now approaching its tenth year of operation. It is a “one-stop shop” for patented medicines owned by different companies and available for voluntary licensing in low- and middle-income countries, so generic versions can be manufactured cheaply. At the moment, it focuses on medicines for HIV, malaria, tuberculosis and Hepatitis C. Respecting existing intellectual property rights (IPRs) for new medicines is key to the success of the MPP, as it allows rights-holders of innovative medicines to widen access to their medicines in lower-income markets without compromising their markets in wealthier parts of the world from where they derive the majority of their profits. This in turn ensures the funds for the research and development that drives medical progress. Despite demonstrating how the market-based system of IPRs can be used to promote access to medicines, Unitaid has also started to pursue energetically what it describes as a “complementary” strategy of encouraging middle-income countries to undermine and attack IP rights.

We create two new companies around academic inventions every day of the year. The critical role such companies play in drug development is clear. The successful integration of public research institutions into the economy is based on the Bayh-Dole Act, which inserted the incentives of patent ownership into the government R&D system. Not a single new drug had been developed from NIH funded research under the patent destroying policies preceding Bayh-Dole. No one is going to spend billions of dollars and more than a decade of effort turning early stage inventions into new drugs or fund a life science startup company without strong patent protection. Yet the patent system and Bayh-Dole are precisely what the critics seek to undermine.

The UN Panel unfortunately squandered its 9-month gestation period. It stuffed into one repository every long-discarded remnant of anti-patent and pro-price-control schemes buried in IP’s historic landfill. Its Report expressly recommended directives to carry out each of them, demonstrating their counterproductive unworkability. After cramming each policy device into a trashcan of unworkable IP stratagems, they waited until the last minute and dumped it on the doorstep of the UN General Assembly. As University of Chicago Economist Tomas Philips concisely explains in this weekend’s WSJ, the UNHLP’s recommendations are nonsensical.

A consistent charge against the patent system is that it denies the poor access to critical medicines. This belief led the UN Secretary General to launch his High Level Panel on Access to Medicines that is supported by groups like Universities Allied for Essential Medicines (UAEM)… As to UN Secretary General’s claim of a “policy incoherence” between IP rights and access to medicines, without the patent system there will be a lot fewer drugs to access here or abroad. That’s a thought he might ponder.

Superbugs have powerful friends in high places. SCOTUS’s patent eligibility criteria emanating from Mayo/Alice’s mysterious “laws of nature” and credible reports of unremitting turndowns by USPTO applicants portend hard times commercializing much of this research, which means its development and testing may never make it to licensed distribution. In Congress, deficit scolds roll back much needed NIH funding while solons clamor for more military weapons that have long outlived their usefulness. Even sexy pandemics like Ebola, Pan Asian Flu, and Zika and competing with Biden moonshots and precision medicine initiatives are forced to forage for the fiscal nourishment they need to compete and commercialize their critical research.

We cannot know what biological killer will next emerge, when it will be born and where globalization’s winds will take it. But we do know that choking-off future private investment in future healthcare needs is foolhardy. And that is what will happen if the UN sanctions this finding. Investment hates uncertainty. And innovation dies without investment. The underdeveloped countries the Panel may seek to protect are often those that suffer first from epidemics like HIV /Aids, Ebola; and Zika. They will suffer first when the next biological scourge begins taking lives.

The pending report of the UN Secretary General’s High Level Panel on Access to Medicines not only attacks the patent system as predicted, but proposes giving the organization oversight of drug development. If you think United Nation functionaries would be more effective than entrepreneurs, you’ll be delighted. If you live in the real world where bureaucracy is the enemy of innovation, you don’t know whether to laugh or cry.

Improving access to needed medicines for those suffering the ravages of disease in developing countries is a serious issue. There are many factors contributing to the problem including poor transportation systems, lack of available health care and education, endemic poverty, trade barriers, systematic corruption and, of course, the cost of drugs. Yet the U.N. Secretary General’s High-Level Panel on Access to Medicines is focusing on the patent system as the source of the problem. The report is due next month. The Panel is to “address the policy incoherence between intellectual property laws and access to medicines.”

The dilemma for developing countries is primarily a function of two things: lack of access to existing medicines and absence of innovation on the treatments and cures that are needed. Admittedly each of these can be linked to intellectual property rights, but poverty is at the heart of both issues. Fundamentally, drugs are not available because there is no market for them and the necessary market incentives are absent. To facilitate innovation, especially on ‘diseases of poverty’ the UN and member states need to commit to cultivating market incentives and removing obstacles.