In an era when health budgets have been severely strained by the expenses of treating COVID-19, the EU is updating laws controlling the 136 billion euro ($148 billion) pharmaceuticals industry in an effort to spur investment and increase access to affordable drugs.
Last winter’s shortages of life-saving medications, including antibiotics and painkillers, as well as the COVID epidemic exposed issues brought on by dwindling European industry, convoluted supply chains, and a lack of readiness for a worldwide public health disaster.
Brussels is under increasing pressure to correct this.
There is little agreement on the reforms other than the necessity to update antiquated standards, which pits the business against patient organisations. The industry includes large pharma and biotech start-ups, which together account for around 1.5% of the bloc’s GDP.
On April 26, the Commission hopes to release a draught of the largest revision to the current medical laws in twenty years.
“The Commission will put forward a balanced and patient-centered proposal, while fully supporting an innovative and competitive industry,” a Commission spokesperson stated.
Brussels wants to reduce the amount of time that businesses have to develop and market medications and treatments in Europe before losing their IP protection. Unknown is the amount of time that will be cut from the wait for generics to hit the market.
But, in an effort to increase access to medications across the EU, the Commission will give businesses the chance to reclaim at least a year of product exclusivity if they launch the product simultaneously in all 27 member states.
Companies are protected for up to 10 years under the enacted 2004 statute. They receive an additional year, bringing the total to 11, in the event that the EU health agency authorises a new use for the medication.
The concept is criticised by biotech companies and drug manufacturers including Germany’s Bayer and Denmark’s Novo Nordisk.
They claim that Europe is already suffering from a loss of competitiveness as a location for research and development (R&D) and innovation.
According to the big pharma lobby EFPIA, during the past 20 years, R&D expenditure in Europe has decreased by 25%.
Market exclusivity restrictions would hurt the development of so-called “orphan” medications, which cure uncommon disorders that only impact fewer than five out of every 10,000 persons in the EU.
While requesting regulatory approval, businesses can be required to list the R&D expenses and public money they received for a new drug. The public may have access to this information.
Consumer advocacy groups applaud this, especially since Brussels gave in to drugmakers’ demands to keep the specifics of COVID vaccine contracts confidential. These groups claim that pharmaceutical companies inflate expenses to justify high prescription prices.
Reduce the number of scientific committees at the European Medicines Agency (EMA) and shorten the time it takes for the regulator to evaluate new medications are two goals of several proposals. On average, the evaluation period is almost twice as long as that of American agencies.
To quickly test revolutionary technology and therapies, the agency may set up a “regulatory sandbox,” which might make it easier for businesses with unique goods to get to market.
The pharmaceutical industry wants to see digital drug pamphlets take the place of paper ones to reduce production costs. Consumer advocacy groups warn that patients may not be adequately informed about prescription medications as a result.