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Parliament’s balanced stand on Unitary SPC regulation rewards innovation via an efficient Unitary SPC system that protects against access to medicines delays


28 Feb 2024



Brussels, 28 February 2024

The position adopted today by the European Parliament on the proposals for the Unitary Supplementary Protection Certificate (SPC) and SPC Regulation recast, led by MEP Tiemo Wolken, is a significant milestone for innovation and access to medicines across Europe in this important legislative process.  

The Unitary SPC will significantly expand the geographical coverage of this IP right that extends the exclusivity (monopoly) of medicines up to 5 years beyond the life of the patent. This “unitary protection” will now cover countries where these drugs are not normally launched or launched very late. The legislation is therefore highly impactful for access to medicines. For this reason, safeguards are essential to prevent misuse of the system.   

The transparency and quality of examination procedures for the grant of Unitary or national SPCs are key principles embedded in the text adopted in plenary by the European Parliament. The Parliament rightly identifies the necessary safeguards for the scrutiny of applications before the granting of an SPC.  This pre-grant opposition mechanism will prevent invalid (non-innovative) SPCs from being enforced and ultimately invalidated in Court, delaying access to generic and biosimilar medicines, as experienced recently for HIV and other multiple essential medicines.  

Moreover, the transparency of SPC expiry dates in the register should not be misused to implement unlawful and anti-competitive patent linkage strategies to delay generic and biosimilar medicines in Member States.  The explicit ban of the unlawful patent linkage introduced by the European Parliament will ensure that competition to blockbuster drugs will not be delayed beyond SPC expiry, as is the case today where, on average, competition begins more than 5 months late. Patent linkage has been declared unlawful by the European Commission in the Pharmaceutical Sector Inquiry Report of 2009.   

Commenting on the report, Adrian van den Hoven, Director General of Medicines for Europe said “The position of the Parliament goes in the right direction and rightfully bans patent linkage. The pre-grant opposition will ensure a timely grant of SPCs for innovative drugs (a maximum 14 months or 12 with an expedited procedure) and prevent monopoly extensions for those drugs that do not have a legal right to an SPC because they are not innovative. The ban of patent linkage will serve access to medicines by preventing pricing and reimbursement or tender procedure delays for generic and biosimilar medicines at SPC expiry. Medicines for Europe will engage constructively with the EU institutions to ensure the most efficient, quality, and fair SPC system possible for the future.”