Flouting IP to deliver cheap Hep C drugs

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With non WTO members such as Algeria flouting intellectual property (IP) it raises the issue of how best to protect and price medicines in the future. In a fascinating interview we spoke to Rachid Kerrar from the Algerian firm Beker about their development of a cheaper, generic version of Gilead’s hepatitis C treatment Sovaldi®.

Sofos®, Beker’s Algerian-made generic, is 70 times cheaper than the originator and the company has already been rattling cages in Europe, pushing regulators and governments to accept the cheaper treatment.

As Rachid Kerrar, Beker’s director general explains, “Gilead’s Sovaldi® [launched in 2013] was the first hepatitis C drug and cost USD 84,000 for a three-month course of treatment in the USA. As hepatitis C is a global health issue [71 million people worldwide are chronically affected by hepatitis C and around 400,000 people die each year from hepatitis C virus-related liver disease] many health organisations were extremely critical of this very high price.” Kerrar claims that Beker stands as a counterbalance to the greed of Big Pharma, which is “playing an inflationist game on prices.”

[Big Pharma is] playing an inflationist game on prices”

Rachid Kerrar, Beker

He continues, “Gilead subsequently founded access programmes within which it distributed licenses to generic players in a list of developing and underdeveloped countries to sell generic versions of the drug under a Gilead license. However, Tunisia, Morocco and Algeria were not included on this list and patients here had to continue sourcing the treatment for about USD 100,000.”

Therefore, Kerrar and Beker took it upon themselves to rectify the situation by developing the generic drug Sofos® and have since moved on to create a wide range of other generic hepatitis C treatments at a much more affordable price than the originator drugs of multinational companies.

Not content to rest on its laurels in North Africa, Beker subsequently attempted to take its treatments to Europe. However, although patients in countries including the US are allowed to cross the border into a neighbouring country and import three months’ supply of a drug for personal use, this practice is strictly forbidden in most of Europe.

Kerrar, unsurprisingly, is a firm supporter of patients being able to go abroad to purchase medicines, claiming that, in the US, “just as a citizen has a right to self-defence, he or she has a right to self-care.” He adds, “Not only does it immediately alleviate healthcare expenditures and entail faster treatment for patients, it gives the government a stronger bargaining position in negotiations with expensive innovators.”

Beker’s approach to the European market, starting with France, therefore revolved around attempting to win over the state. Kerrar recalls, “we approached the French regulator and pointed out that they have a highly stressed hepatitis C budget, with a cost of EUR 46,000 (USD 53,000) for treatment, 250,000 patients and a total expenditure of EUR eight billion (USD 9.2 billion). We did not ask for registration in France but suggested that they might be interested in letting French citizens acquire their hepatitis C treatment legally abroad in the context of personal use.”

Although this initial approach failed, the media storm it created did help move things forward. Kerrar adds, “Though the French authorities refused, Switzerland entered such an agreement only three months later, as our talks with France had raised much public awareness and debate.” He continues, “I think it is about being creative. Although France did not accept our deal, prices of hepatitis C drugs subsequently dropped in the country, meaning that we were able to bring about a small positive change nonetheless.”

With this chastening yet positive French experience behind it, Beker is now looking to expand internationally elsewhere. Kerrar asserts,Where we can register and export our products ourselves, we will do so, and we are already present in several African countries. In others, we will be able to deliver our medication by postal services. Internationally, we are in a good position today, but need to continue focusing on exports.” He jokes that — “France, however, is obviously not on our list at this time!”

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