Panel: Compulsory Licensing Could Address High-Priced Medicines In Europe

The high prices of medicine, which affects access to affordable medicine, was a theme of the annual World Health Assembly over the past week. In one side event, a panel discussed compulsory licensing as a vehicle to be used in combatting the high prices of medicine, not only in developing countries, but in Europe.

The compulsory licensing of patents occurs when a government allows a party other than the patent owner to produce a patented product or process without the patent owner’s consent. This is justifiable under Article 31 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) subject to a number of conditions. Due to the rising cost of medicine, compulsory licensing is increasingly being viewed as a means of making medicine accessible for patients who can ill afford it.

During the 68^th WHA, a panel organised on 21 May by Knowledge Ecology International (KEI) discussed the compulsory licensing of patents on drugs, vaccines and diagnostic tests.

The 68^th WHA took place from 18-26 May.

In recent years, it has become apparent that medicine prices have exceeded the ability of patients to pay not only in developing countries but developed countries as well, sparking discussion among policymakers and others about solutions.

Ellen ‘t Hoen of Medicines, Law and Policy, noted the widespread use of compulsory licensing by governments. KM Gopakumar of Third World Network (TWN) stated that compulsory licensing can bring prices to “rock bottom.”

Andrew Goldman of KEI mentioned concerns that have been raised in relation to compulsory licensing in Romania. For instance, it has been asked if there is a precedent in the European Union for the use of compulsory licensing in medicines. The answer, he said, is “definitely, yes.”

Other concerns relate to questions on regulatory issues in the EU, data exclusivity, and marketing authorisation. Goldman said these issues are “complicated but they are workable.” He also said there are practical concerns about logistics and that these concerns also are workable, and are “getting more workable by the day.”

Gaelle Krikorian, former advisor to the Greens/European Free Alliance, European Parliament, spoke on a rationing situation arising in Europe due to the high cost of the drug Sovaldi (sofosbuvir) which treats hepatitis C. The price of Sovaldi does not allow for universal access to medicine, she said. Krikorian also said there is a rationing situation of cancer drugs arising in some countries.

Manon Ress from KEI discussed the compulsory licensing of drugs for cancer drug TDM1 and stated that much of the “game-changer” medicines, which save lives or make lives better, cost US$100,000 – US$150,000 a year, which is too high “everywhere.”

Ress stated that some governments are showing new interest in compulsory licensing in order to curb high prices. Compulsory licensing may be allowed in the United Kingdom under the Patents Act 1977 (the Act), she said. Section 55 of the Act, “Use of patented inventions for services of the crown,” is one of the grounds that may allow for compulsory licensing in the UK.

Dzintars Gotham of Universities Allied for Essential Medicines (UAEM) described the Cancer Drug Fund. This was created by UK Prime Minister David Cameron and is a “fund to fund the drugs that we decide we cannot fund.”

When the National Institute for Healthcare and Excellence, which assesses which drugs and treatments are available on the National Health Service, decides it cannot fund a drug, then cancer patients can access this fund, he explained. This has been criticised, which contribute to a good environment for compulsory licensing, he said.

Guilherme Cintra of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) stated that: (i) future research needs to be funded (ii) the lowest possible price is not always the sustainable price and (iii) compulsory licensing is not always the most effective way of reducing prices.

He described the common goals of enhancing access to medicine, effective resource allocation, particularly in developing countries and the goal of fostering R&D to address unmet medical needs. Additionally, he stated that compulsory licensing is an option not a solution to the challenge of access to medicine.

Eimear Murphy is a researcher at IP-Watch. She is an LL.M. graduate from American University Washington College of Law in Washington, DC with a specialty in Intellectual Property and Information Policy issues.