The Council has adopted the ‘pharma package’, a new set of rules that will increase patients’ access to medicine and make the EU’s pharmaceutical sector fairer and more competitive.
The package represents a far-reaching reform of the EU’s pharmaceutical legislation and will help ensure fair access to safe, effective and affordable medicines across the EU.
It also seeks to boost the competitiveness of the pharmaceutical industry by cutting regulatory burdens and strengthening security of supply to prevent and manage shortages.
| “With this reform, we have achieved a careful balance between the needs of patients and the importance of maintaining a strong and innovative pharmaceutical industry in Europe. The new rules will promote access to affordable medicines, reward meaningful innovation and help safeguard supplies, while providing a clearer and more competitive regulatory environment for pharmaceutical companies.” |
| — Jennifer Carroll MacNeill, Irish Minister for Health |
Regulatory protection
Companies placing a new medicine on the market will benefit from an eight-year data protection period, meaning they have exclusive rights to data from pre-clinical tests and clinical trials.
They will also receive one year of market protection (the exclusive right to sell a product without immediate competition from generic medicines or biosimilars), which may be extended by an additional year for innovative medicines that satisfy at least two criteria in one of the following ways:
- comparative clinical trials and early application in the EU
- comparative clinical trials and clinical trials in more than one member state
- where comparative clinical trials are not possible, clinical trials in more than one member state and early application in the EU
A second year of market protection can also be granted for products that fulfil an unmet medical need. The total combined period of protection allocated to a new medicinal product cannot exceed eleven years (or twelve years if a transferrable exclusivity voucher is also used).
Availability of medicines
To ensure the availability of key medicines, EU countries will have the power to require pharmaceutical companies to supply medicines benefiting from regulatory protection in sufficient quantities to meet patient needs. Safeguards have been introduced to ensure that this supply obligation is used to meet the needs of patients as opposed to facilitating ‘parallel trade’ (i.e. cheaper exports to other member states).
The ‘Bolar exemption’
The pharma package includes an intellectual property exemption allowing manufacturers to take the necessary steps (such as studies or trials) to ensure that generic versions of a medicine can be made available on day one after the intellectual property rights have expired. The scope of this provision will include the submission of applications for procurement tenders.
Antimicrobial resistance
The pharma package introduces a new transferrable exclusivity voucher incentivising pharmaceutical companies to help combat antimicrobial resistance by developing priority antibiotics. This voucher will grant companies one additional year of market protection for a pharmaceutical product of their choice.
The voucher will be subject to a ‘blockbuster clause’, which limits the potential impact on national healthcare budgets by stipulating that the transferrable voucher cannot be used on products with annual gross sales of more than €490 million in the preceding four years.
Orphan medicinal products
Under the new rules, orphan medicinal products that are developed to treat rare conditions will receive nine years of market exclusivity. So-called ‘breakthrough’ orphan medicines may be granted an additional two years of market exclusivity, bringing the total up to eleven years. An orphan medicine will be considered ‘breakthrough’ if:
- no medicinal product has thus far been authorised in the EU to treat the relevant orphan condition
- the medicine leads to a clinically relevant reduction in sickness or mortality rates resulting from that condition
Next steps
The regulation and directive that make up the pharma package now need to be adopted by the European Parliament. They will then enter into force following publication in the EU’s Official Journal.
- Pharma package (regulation)
- Pharma package (directive)
- EU law tracker (regulation)
- EU law tracker (directive)
- The pharma package: new EU rules on medicines (background information)