Scott Bass explains why taking a multi-disciplinary, multi-continent approach to the planning of clinical trials will help you anticipate regulatory changes and ward off investigations.
- Pricing in sheep’s clothing – Pharma enforcement is increasingly targeting the price of medicines in many different guises. There are multiple ways for regulatory and competition/antitrust authorities to put less than transparent downward pressure on pricing. Increasingly it’s being seen as early as in the clinical trial phase. Pharma companies should: (a) consider carefully how costs are allocated from day one of clinical trial planning and (b) undertake a multi-disciplinary assessment of all the measures being taken in the countries in which they are active which have the potential to affect pricing and reimbursement, including in the design of comparative -effectiveness trials. They should also ensure they treat competition law principles as paramount.
- Healthcare belt tightening post-COVID-19 – There are various examples across the globe of governments looking for ways in which to cut public spending on medicines. For example, The Netherlands has begun to develop its own pharmacy-compounded products as an alternative to authorised products, and as a benchmark for the pricing and reimbursement of the authorised products that they seek to replace. A similar situation could be evolving in Belgium. Pharma companies would therefore be well advised to engage in multi-continent reimbursement mapping to anticipate similar developments which may spread.
- AI tentacles – Governments have an increasing expectation that pharma companies will be employing artificial intelligence (AI) as a means of identifying pharmacovigilance and cost-effectiveness data but also increasingly in their drug development process which is expected to have major financial savings. Over the last ten years AI has been increasingly used, particularly post-COVID-19, to facilitate the collection and analysis of real world evidence. Pharma companies should carefully consider all implications of the manner in which they analyse health care-entity AI data. That same data may be used to deny comparative-effectiveness-based approvals or later to limit approved indications.
- Combo products creep – Pharma companies should be prepared for clinical trials to increasingly focus on combinations of drugs and medical devices, not just in Europe but globally. Combo products have significantly different issues in clinical trials design, not least because many countries place medical devices in different regulatory buckets.
- Microtargeting: the new promotion concern – Pharma companies should be thinking carefully about their clinical trial strategy in the light of the rapid growth of microtargeting in social media promotion. In addition to a refreshed focus on big concepts such as data privacy, off- label promotion and pre- approval promotion, companies will increasingly need to factor in how microtargeting changes both their risk analysis and the focus of potential government enforcement actions.
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