The EU is revamping laws governing the 136 billion euro ($148 billion) pharmaceuticals industry aimed at reviving investment and boosting access to affordable drugs at a time when health budgets have been drained by the costs of treating COVID-19.
Shortages of critical drugs from antibiotics to painkillers this winter and the COVID pandemic exposed problems caused by declining manufacturing in Europe, complicated supply chains and a lack of preparedness for a global public health emergency.
Brussels has faced growing pressure to fix this.
The reforms however pit the industry – from big pharma to biotech start-ups which together represent about 1.5% of the bloc’s GDP – against patient groups, with little consensus other than a need to overhaul outdated rules.
The Commission aims to publish a draft – the biggest overhaul of existing medical laws in two decades – on April 26.
A Commission spokesperson said: “The Commission will put forward a balanced and patient-centred proposal, whilst fully supporting an innovative and competitive industry.”
Brussels plans to shorten the period of intellectual property (IP) protection companies receive to develop and sell drugs and treatments in Europe. How much time will be cut from the period before generics can enter the market is unknown.
But in an attempt to improve access to medicines across the EU, the Commission will offer companies an option to gain back at least one year of exclusivity for a product if they launch it at the same time in all 27 member states.
Under the existing 2004 law, companies get up to 10 years of protection. If the EU health regulator approves a new use for the medicine, they get another year, bringing the total to 11.
Drugmakers like Denmark’s Novo Nordisk (NOVOb.CO) and Germany’s Bayer (BAYGn.DE), and biotech firms criticise the plan.
They say Europe is already losing out as a destination for research and development (R&D) and innovation is suffering.
Big pharma lobby EFPIA says R&D investment in Europe has fallen by 25% over the past 20 years.
Cuts to market exclusivity would damage work on so-called “orphan” drugs which treat rare conditions affecting fewer than five in 10,000 people in the EU, they warn.
Companies may be obliged to disclose R&D costs and public funding received for a new drug when filing for regulatory approval. This information might be made public.
Consumer groups, who say pharma companies exaggerate costs to justify high drug prices, welcome this, particularly after Brussels ceded to drugmakers’ requests to keep terms of COVID vaccine contracts secret.
A MODERN REGULATOR
Several proposals aim to streamline the European Medicines Agency (EMA), reducing the number of scientific committees and cutting the time the regulator takes to review new medicines. The review period is on average nearly double that of U.S. authorities.
The agency may establish a “regulatory sandbox” to rapidly test innovative technologies and treatments, potentially easing the path to market for companies with novel products.
The industry hopes to see paper leaflets for medicines replaced by digital ones, cutting production costs. Consumer groups warn this risks patients having inadequate information about prescription drugs.
TACKLING DRUG SHORTAGES
The reform will propose that companies notify the EMA earlier of shortages or withdrawals of their products and hold bigger stocks of medicines deemed essential, such as the antibiotics in shortage this winter.
Brussels believes this will help avoid future shortfalls, but companies say it is difficult to predict supply issues months ahead.
Instead, companies want the EU to establish a bloc-wide database on medicine consumption to help forecast surges in demand like those that contributed to this winter’s crisis.
The draft also may propose empowering the agency to grant compulsory licences, which would halt market protection for some medicines in the event of a public health emergency.
After decades without a breakthrough in antibiotics discovery, the EU wants to incentivise drugmakers to invest in developing new ones. Experts warn the problem of drug-resistant “superbugs” is growing and could spawn a global emergency worse than the COVID pandemic.
Companies bringing a new antibiotic to market may get an additional year of exclusivity in the EU for another medicine they have on the market.
Fourteen member states have written to the Commission, criticising the idea as costly and harmful for consumers as it could disrupt the generic drugs market.
WHEN WILL THE CHANGES BECOME LAW?
Once the Commission publishes the draft, the European Parliament, Commission and member states will thrash out final details.
Lawyers representing industry don’t expect legislation to be adopted before 2025. Next year’s EU elections may delays things further.