- Align Systems with New Clinical Trials Regulation. The European Medicines Agency has begun its work setting up the single EU portal for the assessment of clinical trial applications. Industry should monitor and implement technical specifications to be issued by the EMA in 2015, consider the organizational and process changes required by the single EU portal, and ensure that the new timelines are reflected in business plans.
- Adapt to EMA Transparency Policy. On January 1, 2015, the EMA’s policy of publishing clinical study reports submitted as part of marketing authorization applications came into force. Commercial confidential information can be redacted from clinical study reports once they have been submitted to the EMA. As it is the applicant’s responsibility to propose redactions, it is highly recommended that sufficient resources are invested in reviewing and redacting clinical study reports.
- Finalize Transition towards New EU Drug Safety Reporting Rules. The EMA is expected to release the three outstanding modules on Good Pharmacovigilance Practice (on international cooperation, involvement of patients in pharmacovigilance activities, continuous pharmacovigilance and ongoing benefit/risk evaluation). This will complete the implementation of the new pharmacovigilance legal framework adopted in 2010. Companies should devote appropriate resources to compliance checks, in anticipation of further inspections and enforcement proceedings.
- More Sunshine over Interactions with HCPs. Under the EFPIA Disclosure Code, companies are expected to begin recording transfers of value to healthcare professionals and healthcare organizations. Sunshine rules for medical devices are also to be expected; for instance, a pilot scheme is currently under way in the Netherlands. Industry should ensure that it adopts appropriate systems to record and, in due time, report transfers of value to healthcare professionals and healthcare organizations in the EU.
- Identify Opportunities for Use of Adaptive Pathways. The EMA is moving away from the concept of “adaptive licensing” in favour of “adaptive pathways,” a new initiative delivering a flexible life-span approach in order to bring new drugs to patients at an earlier stage. Industry should identify products in their pipeline that may be eligible for this new regulatory route.
- Reassess Requirements for Consumer Goods. In the food sector, expect increasing enforcement of the newly-applicable EU Regulation on the provision of Food Information to Consumers, the adoption of delegated acts for Foods Specific Groups (formerly Foodstuffs for Particular Nutritional uses, or PARNUTs), and the potential adoption of a new Regulation on Novel Foods. Also, it is recommended that companies pay close attention to the revision of the General Product Safety Directive, as the outcome may prompt changes to safety reporting and notification systems for virtually all types of EU-marketed consumer goods.
- Engage in Development of New Data Protection Policy. As the Data Protection Regulation is expected to be adopted before the end of this year, industry should continue to monitor and/or participate in legislative developments, and begin to consider the impact of possible future rules on their organization and systems in order to minimize the risk of exposure to the (likely significant) financial sanctions in case of failure to meet new data protection requirements.
- Strengthen Medical Device Development and Compliance Programs in Anticipation of New Medical Device Regulations. Two proposed Regulations intended to replace the existing EU legal framework governing medical devices and in vitro diagnostics (IVDs) remain under discussion but are scheduled to be adopted in 2015. Their adoption would result in additional, stricter requirements and increased oversight by regulators. In the meantime, regulators have already intensified surveillance and enforcement activities.
- Assess Competitive Effects of Joint Purchasing Arrangements. Pricing and reimbursement authorities are increasingly sharing information and moving closer towards joint purchasing of high-cost drugs, including biologicals. Companies should consider the competition law implications of this and conduct stress-tests on market entry plans.
- Prepare Defenses to Pricing and Reimbursement Pressure. Expect a significant rise in refusals to pay for expensive drugs and increased competition between biologicals. Industry should consider reviewing business plans for pipeline products from this perspective and conducting or commissioning further health economics research to demonstrate the public health value of your company’s products.
Maurits J.F. Lugard
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