Access planning: How do pharmaceutical companies plan to make new products quickly accessible after launch?
New medicines and other life-saving products must be made rapidly available to patients who need them, wherever they live. This requires advance planning by the pharmaceutical companies developing the products.
Before new products are approved for sale, companies can put access plans in place, such as equitable pricing strategies or voluntary licensing arrangements, to accelerate the speed at which products become accessible. Access plans are expected for projects that are in Phase II clinical development and onward, referred to here as 'late-stage projects'.
The Access to Medicine Index examines whether companies are planning ahead in this way, and what these access plans look like.
Access plans are concrete tactics that help ensure new products are accessible and affordable for patients once they become available on the market. Projects that have fairer pricing strategies - here termed 'equitable pricing', wide-spread registration strategies and broad licensing agreements in place have the best outlook for access.
- Registration preparation: Commit to filing products in all countries where there is a need, and prepare registration dossiers in parallel with EMA, FDA or PMDA approval.
- Non-exclusive voluntary licensing: Voluntarily enter licensing agreements under pro-access terms to facilitate generic entry.
- Patent waivers: Publicly waive patent rights and pledge not to enforce patent rights in specific territories.
- Supply and demand plans: Plan for and align with other actors along supply chains to ensure the timely supply of quality product and prevent stock-outs.
- WHO prequalification: Submit products to WHO’s prequalification process to allow for UN procurement and accelerate registration process in countries with weak national regulatory authorities.
- Equitable pricing strategies: Set prices within the ability of specific populations to pay, with reference to a range of socioeconomic factors.
- Product donation plans: Identify populations with no capacity to pay for the new product and prepare to donate as appropriate, working with local partners.
- Access planning through partnership: Conduct R&D with organisations that explicitly commit to using access plans.
Out of 1,314 R&D projects, 213 are supported by access plans
The 2018 Access to Medicine Index identified 1,314 R&D projects for the 77 diseases, conditions and pathogens covered by the Index in this analysis. Of these, 213 projects (16%) have plans in place to help ensure the product is made affordable and accessible once it becomes available on the market. When looking solely at late-stage R&D projects just 96 (19%) of these projects are supported by access plans.
Figure: Proportion of R&D projects that have an access plan
What is the most common type of access plan?
Projects are more likely to have an access plan when they are in collaboration with other publicly or privately funded partners. In 2018, more than half of projects with access plans were found to be run through such partnerships. These partners can provide funding, resources or expertise, and they incorporate pro-access clauses into contracts to ensure that products are accessible and affordable upon market approval.
Figure: Breakdown of the type of access plans in place
Which disease types are mostly covered by access plans?
Projects for neglected tropical diseases (NTDs) have the largest proportion of access plans in place. NTDs are a group of infectious diseases that collectively affect over one billion people worldwide, most of whom live in the world’s poorest populations. By contrast, many projects that target non-communicable diseases, such as cancer and heart disease, lack a clear strategy on how they will reach patients living in low- and middle-income countries.
Figure: Percentage of late-stage R&D projects that have access plans for each disease category
Novartis Access Principles to establish access plans during development
Novartis has established a systematic approach to develop access strategies for each of its new medicines during development. As it is developing products that target some of the most pressing needs in low- and middle-income countries, establishing access strategies for all new medicines could have a significant impact in these countries.