The pharmaceutical package reform to overhaul the regulation of incentives, destocking and compulsory licensing, among other issues, has finally been presented by the European Commission this week. The reform is intended to respond to the aims of both the Pharmaceutical Strategy and the Intellectual Property Action Plan presented in 2020.
Although the measures incorporated are insufficient to solve structural problems of the pharmaceutical innovation system, and some of them even go in the opposite direction, Salud por Derecho welcomes several of the proposals incorporated in the new measures because they favour three aspects that are crucial to guarantee justice and equity in access to medicines and health technologies. These are: reducing lead times for more affordable alternatives to on-patent medicines; removing certain barriers to the implementation of TRIPS flexibilities; and promoting transparency of public investment in medicines.
On the one hand, the current incentives for data exclusivity and market protection are reduced by two years, although possibilities for extending the period are incorporated if a number of conditions are met, such as a paediatric plan or ensuring that the medicine reaches all 27 Member States. A similar situation will be found in the specific legislation on orphan drugs where protection is reduced by one year and the temporary extension is also subject to conditions.
A proposal for the creation of a “European compulsory licence”, which gives the possibility to suspend data and market exclusivity and export exclusivity between countries, has also been introduced in the patent reform. It is a solution proposed by the European Commission in emergency situations throughout the European region.
“While we find this proposal very interesting and on the right track, we are concerned that it can only be used when EU emergency mechanisms are activated and not in other public health crisis situations. The scope of when this instrument can be used is certainly something we hope the European Parliament will review,” said Irene Bernal, head of Health Research and Advocacy at Salud por Derecho
However, while incentives are being cut for one group of medicines, new ones are being introduced for others, such as transferable exclusivity in the form of vouchers for antibiotics, known as TEVs. TEVs are an incentive given to companies that develop a new antibiotic that will allow them to extend the intellectual property protection of any other drug in their portfolio or to sell it to other companies. In other words, a double incentive that, while initially aimed at the developing company – mostly medium-sized biotechs – would mainly benefit those who would ultimately buy it, probably larger companies interested in prolonging the protection of their blockbuster.
“This incentive proposal is not only ineffective in stimulating innovation in antibiotics, but will delay the entry of generic medicines that could make drugs more accessible to the entire population. In its current form it seems more like an incentive for a speculative economic transaction than a reward for a concrete outcome for an antibiotic innovation that meets a health need. We hope that in this period in which this proposal is being debated in the European Parliament, there will be support for other alternatives where global access gains relevance“, says Jaime Manzano, Policy and Research Officer at Salud por Derecho.
Transparency is also a crucial issue for a fairer and more equitable pharmaceutical policy. We therefore welcome the Commission’s proposal on reporting the public funding received for the R&D of the medicinal product to be authorised. Public investment in R&D is a cornerstone of EU science policy, but it is also legitimate to know the public share of each innovation. The European Parliament has the possibility to expand on this with proposals to make the public contribution even more visible and to ensure affordability of products.
With regard to shortages, the European Commission is also in favour of concrete plans by companies that can prevent them and, moreover, with a certain amount of time in advance. However, as with other proposals, this one should be more ambitious and ensure stocks that further avoid such temporary market fractures.