In this week’s news, EU protections like SPCs impact R&D, access and prices says EC, FDA approves 1st generic through new pathway, ABPI chief talks Brexit and more…

SPCs and data protections stimulate R&D but limit availability says EC

Longer protection periods stimulate pharma R&D investment but delay post expiry price reductions and limit access according to an EU report.

The report looked at the economic impact of incentives and rewards in Europe, with a specific focus on Supplementary Protection Certificates (SPCs) and regulatory data protection.

The authors wrote that, “We find that a longer effective protection period stimulates research and development into new medicinal products.”

The implication is that shorter protections dissuade industry from investing in R&D because they will have less market exclusivity. Indeed, the authors said changes will impact R&D investment at any firm which suppliers the EU.

In addition to stimulating R&D investment, current protections also delay price reductions when generics do enter the market according to the authors.

“We find that when generic medicinal products enter the market their price is on average 50% lower than the initial price of the corresponding innovator product in the first five quarters after the launch of the generic product. This means that the innovator product remains more expensive.”

Limiting access

They also suggested that current incentives limit access to products in some European Union (EU) member states.

“We find that companies choose to launch more medicinal products faster in larger and wealthier countries” the authors wrote, adding “Hence, not all new products are made available in all European countries and not at the same time.”

US FDA approves new generic through competition-stimulating pathway

The US Food and Drug Administration (FDA) has approved a generic hypokalemia treatment through a new pathway designed to stimulate competition.

The Competitive Generic Therapy (CGT) designation was created to expedite the development and review of a generic drug for products that lack competition according to agency commissioner Scott Gottlieb.

“This new generic drug application was approved in its first cycle of review. This approval demonstrates that the competitive generic therapy pathway is efficient and open for business.”

The newly approved drug, which is made by Apotex, is a version of potassium chloride indicated for the treatment of low potassium levels in patients on diuretics if diet management is insufficient or dose reduction is not possible.

Encouraging generic competition also has the potential to address the practice of price gouging, whereby the sole manufacturer of a product raises its price in order to take advantage of its dominance of the market.

ABPI chief says biggest challenge is Brexit

ABPI chief Mike Thompson has described Brexit as his industry’s biggest challenge, but also be a catalyst for change.

Thompson set out his thoughts on the UK’s withdrawal from the European Union in an interview with the Medicine Maker last week.

He told the publication, “We became comfortable with the UK being a gateway to Europe. Regardless of the Brexit outcome, this is likely to change.

“We must, therefore, stand on our own two feet and recognize that we’re a market worth just 2.3 percent of the global marketplace. To attract global companies, we’re going to have to be the best,” he Thompson continued, also suggesting that a ‘no-deal’ Brexit can be avoided.

“There is a scenario that will present real challenges in supplying our medicines to patients across Europe. But I believe that politicians have great skill in going to the precipice and then turning back – and finding a way out.”

Also in the news

STAT looked at what impact US patent reforms would have on drug prices.

Drug firms and their chemical industry suppliers have started ramping up stockpiles in preparation for Brexit according to CEN.

The UK Cell and Gene Therapy Catapult has published its annual report.