The Purchasing Controversy of an Innovative Drug to Cure Hepatitis C

The announcement of the discovery and manufacturing of a new drug with a high probability of curing an infectious disease is always received with joy. The negotiations between states and pharmaceutical companies for the procurement of medicines, however, may take more time than it is desired and expected by the people who are suffering from the condition. The procurement of Sofosbuvir, an innovative drug which cures hepatitis C in 90% of the cases, was recently at the centre of controversy in Portugal. There was a possibility of purchasing the drug jointly with other European countries but on its own the Portuguese government ended up achieving the best purchasing agreement in Europe, according to Gilead Sciences, a pharmaceutical company.

Although the European Medicines Agency approved Sofosbuvir in January 2014, the Portuguese national authority for medicines, Infarmed, only accepted its use on the National Health Service in September and subject to a special permission. The drug was only to be used on patients who suffered from liver cirrhosis or whose liver functions had gone into decompensation. The reason given for the restriction was the high price asked by the pharmaceutical: 42 thousand euros per patient. Until the beginning of January this year, only 67 patients had been given the drug. Demands for it to be given to all hepatitis C patients flooded the media after one patient died without receiving the treatment.

The Portuguese Ministry of Health and the North-American Gilead Sciences reached an agreement at the beginning of February. The major feature of the agreement is that the Portuguese government will only pay for each person being treated and not for the number of treatments used. The company will provide additional treatments until the patient is cured. The price agreed for each patient has not been disclosed, but the Portuguese health minister said that it has been halved since the beginning of the negotiations.

The agreement concerns two drugs produced by Gilead Sciences: Sofosbuvir and a more recent one, approved last December, which contains Sofosbuvir and Ledipasvir. It will last for two years, as other innovative drugs may be available in the future. All the patients infected with hepatitis C are to be treated. Currently, there are 13 thousand people with hepatitis C registered in Portuguese hospitals. Some of the patients may not need to be treated with these drugs, as in some cases the infection clears without treatment and others can be treated with other drugs depending on their genotype.  As it is, some five thousand patients are to be given the drug each year.

Joint Procurement Agreement

Before the conclusion of the agreement, the possibility of buying the innovative drug together with other European countries was considered. Infarmed put forward to the other European medicine authorities a proposal for a joint purchase of the drug, in order to reduce the price asked by the pharmaceutical company.

Infarmed’s aim was to index Sofosbuvir price in Europe to the lower one being practiced in Egypt, but taking into consideration the difference in the Gross Domestic Product (GDP). Since the EU’s GDP is 5.93 times higher than the Egyptian, the price to be paid for the drug would have  had to be correspondingly higher. The advantage of this proposal for the company was that all patients infected with hepatitis C in all the countries participating in the joint procurement would be treated.  

Although the Spanish health ministry was also interested in a joint purchase with other EU member states, no agreement was reached as some governments had already approved the reimbursement of the drug. 

The possibility of EU member states getting together in order to purchase medical drugs stems from the difficulties some countries faced when buying vaccines for the H1N1 pandemic in 2009. A year later, the Council requested the Commission to start outlining a joint procurement of vaccines in case a new pandemic occurred. In April last year, the Commission approved a Joint Procurement Agreement which allows member states to acquire pandemic vaccines and other treatments together.

The main aim of the agreement is to make sure member states have access to the necessary pandemic vaccines and medicines at adequate prices in case of a cross-border health threat. However, the agreement can also be extended to cover the procurement of medical countermeasures for other infectious diseases, such as polio, anthrax or hepatitis C. Currently, 20 member states have signed the Joint Procurement Agreement. Any of the signatory countries can then make a proposal to others to purchase treatments together. Only after signing a contract made on the basis of a joint procedure is a financial commitment made.   

The possibility of member states purchasing medicines together in order to reduce prices may be of use in the future, as more innovative drugs for other diseases are expected to be available.