In 2010, the European Ombudsman ruled that the European Medicines Agency should open access to clinical trials data when companies applied to get their drugs on the market. The ombudsman decided public health was more important than considerations of commercial confidentiality.
In February this year, the US pharmaceutical company AbbVie, who make Humira – the best-selling drug in the world today – and another company Intermune independently took legal action against the EMA’s open access policy after they were tipped that competitors had requested access to clinical study reports and the EMA was going to grant it. In one of the most important healthcare legal actions ever taken, the court upheld the pharmaceutical companies' positions.
Six months later, the European Federation of Pharmaceutical Industries and Associates (EFPIA), convened a meeting in Brussels to look at the issue of trial data access. Neal Parker, a senior legal figure within AbbVie, said it was in “the public health interest to maintain commercial confidentiality to drive business forward.”
While “a vast amount of data was released without controversy”, he said, a competitive landscape meant that the remaining data had to be in the control of companies.
Adverse effects and Eastern threats?
However, Parker caused a stir by intimating that data on adverse drug reactions should be treated as commercially confidential – an unusual admission. To protect these and other data such as demographic information and lab results, the company were seeking corporate privacy rights.
But there was another little remarked intervention close to the middle of the meeting, when Richard Bergström, the EFPIA’s Director General, intervened to say that most of the organisation’s industry members were “quite relaxed” about data disclosure. For most products, apart from products in highly competitive fields such as biologics (products created using biological processes rather than synthesising chemicals and which include vaccines), there would be no issues. But Bergström added:
“You might get companies from South Korea or China breathing down your neck trying to copy your technology, then you get extra sensitive.”
This comment raises a question. While the commentariat have been debating access to clinical trial data in the media, is the action actually elsewhere and about something entirely different?
EMA licenses new rival
In September, a little over two weeks after this meeting, the EMA provisionally approved infliximab biosimilar (trade name Inflectra), an antibody drug for use in the same inflammatory diseases AbbVie’s Humira is used for: rheumatoid arthritis, Crohn’s disease and psoriasis.
Infliximab is the core compound in Remicade, another drug used to treat Crohn’s disease and rheumatoid arthritis and developed by Johnson & Johnson. Remicade was one of the first biologics or MABs (monoclonal antibodies) type of drugs, of which Humira has become the most famous.
The branded pharmaceutical industry has always fought hard against generic drugs which eat into their blockbuster profits and they have fought tooth and nail to stop “generic” versions of any of these biologics being launched based on the argument that no generic can be identical to its parent biologic.
There are in fact irreducible differences between all of the original MABs and derivative biologics. And this has given rise to the concept of the biosimilar, to which the new Inflectra belongs and which can be produced more cheaply. And the pipeline for new drugs is so poor that blocking biosimilars has become almost a life or death issue for the branded companies.
Cats in bags and spiralling costs
So where do Richard Bergström’s comments fit into all of this and did he let the cat out of the bag by mentioning Korea?
The newly approved Inflectra was made by Celltrion – a Korean company – working in collaboration with Hospira, a new kind of pharmaceutical company that has emerged to help develop biosimilars. Hospira, based in both the US and UK, is the first company to major on the market development of biosimilars. It filed the application to market Inflectra in America and Europe (and as Celltrion’s Remsima in other markets).
This could lead to the price of biologics, which can cost anywhere between $20,000 and $500,000 (£12,000 - £300,000) per year, falling dramatically: Inflectra will likely cost 33% less than Johnson & Johnson’s Remicade and will have knock on effects for Humira.
Margaret Chan, Director General of the World Health Organisation, said earlier this year:
The costs of many new medical products are becoming unsustainable for even the wealthiest countries in the world. [Of the 12 cancer drugs approved last year], 11 were priced above the $100,000 per patient per year. This price is unaffordable, for most patients, most health budgets and most insurance companies. These are problems for all countries, not just the developing world.
Before the MABs, big insurance companies like UnitedHealth Group, Humana and others simply paid out on new drugs. They offered a reimbursement rather than an insurance service. But now that biologics are so much more expensive than older drugs, companies in this area, especially larger companies, have had to become insurers rather than just reimbursers. And the development of biosimilars offers these insurance companies huge leverage. Companies like Hospira and Celltrion have a chance to change healthcare radically, but it involves competition – and perhaps a commercial threat from the East.
AbbVie was until recently Abbott Laboratories, one of the world’s biggest pharmaceutical companies, and wields significant power. Big pharma argue that protecting commercial interests protects their investment – and without it we wouldn’t have new drugs.
But while campaigners fight for more transparency over clinical trial data, and by extension information about adverse effects and risk that some medicines may pose, there is a two-fold problem which all this reveals: how commercial interests mean more expensive drugs and treatment potentially denied to those who desperately need it, despite us knowing that there may be a way to help.
The timing of AbbVie’s action against the EMA policy suggests that this was not really about transparency at all but about trying to deter the EMA from licensing Inflectra/Remsima, and a raft of cheaper, more available drugs. It was filed at a time when the threat it posed might still have played a part in the considerations of EMA or the politicians to whom EMA has to answer.
The European Court is due to deliver an initial judgement in the next few weeks on the decision to allow the trial data to be withheld. Transparency (and access to safety data) will be dealt a severe blow if AbbVie and Intermune triumph. And we may well also be worse off without cheaper competitive biosimilars on the market.