Get the Price of Prescription Drugs Down: Change Patent Laws

Get the Price of Prescription Drugs Down: Change Patent Laws

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Hedley Rees started this petition to Bernie Sanders (Senator) and

#PatientsNotPatents

Patent laws are archaic, and they’re unfairly gamed by pharmaceutical companies applying for patents on the ‘idea’ that one molecule, (yes, they are patenting molecules) might treat a disease. No proof is needed, merely a concept.

By patenting thousands of molecules, the hope is that they might get approval for a new blockbuster - Viagra or Lipitor ($130BN in sales over 14 years).

The US Government has official figures showing that out of 10,000 patented molecules, only one gets to market.

That’s not the end of it; 250 of them will undergo vastly expensive pre-clinical testing, where millions of animals are culled, to select five molecules to begin human clinical trials with.

Four of the five clinical trials will fail to gain approval, where patient hopes are raised only to be dashed by the last crushing disappointing failure.

Bringing this closer to home, let’s look at drugs for Alzheimer’s. Over 30 drugs in the last 15 years alone have failed at late-stage clinical trials. 30 drugs. Most were based on a theory that a protein named amyloid beta was interfering with the brain. More recently, another protein name tau was claimed to be the culprit. Both theories have failed to make any impact and a number of the large pharma companies have abandoned this horrible condition altogether.

And this is costing us - you and me - money, not to mention lost opportunities in medicine creation. This wasteful, almost casino-type business model is costing the planet $100Bns in wasted effort and resources.

You may be wondering why is this happening? Well, companies have 20 years from patent award to expiration. If it takes 13 years in R&D and it gains approval to sell, they only have 7 years (the remaining patent life) to recoup their expenses and make a profit. It’s a case of more haste, less speed. In the rush to get human trials, little attention is paid to the suitability of a molecular compound’s ability to navigate the route through development; hence, only one in 10,000 gets through.

And this is down to patent law (known as compound claims). Whilst it may have been suitable 50 or more years ago, it desperately needs to be changed, to stop the shocking failure rates; and we want to catalyse the process of change.

We want pharma companies to provide evidence that a potential drug is going to be:

  • safe
  • effective compared with drugs already on the market
  • manufactured to the required quality

The predictive technologies for this exist in our universities and SMEs, but pharma companies are not using them or even looking for them. They are doing what they’ve always done for the last 50 years – and patients (that’s you and me) are suffering as a result.

Medicines cost far more than they should, and the much-needed drugs are not being brought to market.

For this to change, it would require the regulatory authorities (e.g. FDA/EMA/MHRA/NICE) to have far greater involvement in patent awards. Currently, this is entirely the domain of the Intellectual Property Office (in the UK).

If these health agencies were more involved, with their deep and specialist knowledge, it would add an important dimension to the assessment of the suitability of a drug to be awarded a patent; and also make sure enough thought has gone into the supply chain. Questions should be asked, such as:

“what is known about the toxicology of the molecular compound?”

“what consultation with expert physicians in the disease has taken place?”

“How does it compare with the standard of care?”

“Is its suitable for manufacture at scale, given its chemical and biological properties?”

“what work has been carried out without testing in animals and humans (known as ex vivo)”

“who will benefit?”

“How will they benefit?

The key to this is to prevent medicines developers from rushing off with an idea, when the involvement of experts could help prevent a failure waiting to happen. That is in no-one’s interest.

This will also steer medicines developers to consult more widely with healthcare professionals who understand the particular disease being considered in some depth – without the intense secrecy that patents bring with them (what happened to the days of sharing new knowledge in the medicines industry?).

By signing this petition, you’ll be helping us achieve this change. Gandhi said, ‘be the change’, so we are.

We want to start educating the public on this wasteful system, and if we can get 10,000 of signatures for this petition – we have a case for Parliament to look at it.

We already have a paper with the Clerk of the House of Commons Health and Social Care Select Committee, requesting an inquiry into patent law – see here.

If we get that inquiry, it will bring the whole thing into the public domain, as these inquiries are broadcast on Parliament TV.

So, please do sign, and then share this with all your friends and family, because we can’t make this change alone.

Finally, David Mitchell, President for Affordable Drugs (P4AD) made the video above, and if you’ve not watched it, we encourage you to.

David has a rare blood cancer and expensive drugs are keeping him alive, but the system is against him. He is campaigning tirelessly to bring sense and reason to drug pricing.

If we can change the patent rules, then the system will have to change.

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