Gilead Sciences’ hepatitis C treatment, Sovaldi, has been a regular feature in healthcare news of late, not least because it offers that most elusive of gifts: a cure. There has been much discussion about its price, but also a recognition of the value that this drug offers to society. If a patient is successfully treated with Sovaldi, ongoing treatment costs are nullified, including significant expenditure on care, and that patient may return to work delivering further economic benefits to society.
However, on 10 February, Médecins du Monde (Doctors of the World – MdM) filed a challenge against the patent for Gilead’s drug. The NGO maintained that while the medicine clearly represented a real breakthrough in the treatment of hepatitis C, it was not innovative enough to warrant a patent, particularly at the price that Gilead was charging. MdM argues that if they win the patent challenge, this would open the gates for generic companies to enter the field, copy the drug and sell it for a considerably lower price.
MdM is not alone in challenging the patent. To date a total of ten challenges have been registered. What is strikingly obvious, though, is that MdM has missed the point completely and is taking aim at the wrong target. The bottom line is: without the patent, Sovaldi would never have been developed and millions of people across the world would be left without the possibility of a cure for this often debilitating condition. This selective memory approach to the issue offers no comfort to hepatitis C sufferers.
MdM has also mistakenly pointed to the affordability of Sovaldi as a result of its high price. What the NGO chooses to ignore, though, is that the manufacturer has differentiated the price across the range of countries where the drug has provided to patients. This represents an underlying inconsistency in MdM’s position.
EFPIA may not be in a position to assess the validity of Médecins du Monde’s claims against Gilead’s patent, but we have serious concerns that the NGO is challenging a patent on grounds that are wholly unrelated to the patent system. To put it plainly: the price of a product plays no part in the decision of a patent office to grant a patent. Medicines prices are in fact determined by those who buy them. This means, for the most part, governments and not patent offices who have no influence over prices whatsoever.
EFPIA acknowledges that European governments understandably may be concerned with debt and liabilities in different areas, including healthcare. However the overall medicines bill in Europe is currently under control and does not pose a threat to the sustainability of healthcare financing in Europe. In fact, overall medicines across Europe represent less than 15% of total expenditure – although variances exist among therapy areas.
To achieve both economic and health care efficiency, it makes sense to limit spending on low benefit areas and enhance spending on cost-effective areas, such as primary care and medicines, especially in areas of societal priority. We must ensure that health spending is as smart as possible, which might mean greater upfront investment, but higher efficiencies in the long term.
Industry is prepared to play its part in getting this right by showing flexibility and is engaging with payers around the world. Our objective is not to promote spending on health or medicines at all costs, but decisions relating to public resource allocation should be informed by understanding the trade-offs involved where possible.
It must be underscored, though, that healthcare budgets and the patent system are distinct and separate entities. What the patent system is in fact designed to do is to support the development of new drugs for patients by offering firms an incentive to invest in innovation. It also serves to ensure the dissemination of scientific information to encourage research and the development of further innovative and even more effective drugs for posterity. No suitable alternative system has so far emerged that is capable of engaging comprehensively with the clinical trials process to bring new medicines to patients.
Questions may continue to be raised about the price of innovative drugs, but mostly this will be done while ignoring the medicine’s significant value to disease sufferers and the wider society. There is a need to move away from traditional categorisation considerations and to embrace a more holistic approach to healthcare issues. This means abandoning the silo mentality of focusing solely on price and towards more joined-up thinking that includes the outcomes and benefits for patients and society.
In short: let’s not kill the patent system for decisions it cannot control.1