On July 6th, EMA and HMA released a joint strategy for the next five years for a 2-month public consultation. The publication of the final strategy is expected in November 2020.

Description and priorities

The draft strategy is described to detail “how the European medicines agencies’ network can continue to enable the supply of safe and effective medicines that meet patients’ needs in the face of challenges posed by ever-accelerating developments in science, medicine, digital technologies, globalisation as well as emerging health threats, such as the COVID-19 pandemic.”

1. The availability and accessibility of medicines
2. Data analytics, digital tools and digital transformation
3. Innovation
4. Antimicrobial resistance and other emerging health threats
5. Supply chain challenges
6. The sustainability of the network and operational excellence

Feedback

The public had the chance to provide their feedback until 4th of September 2020 on the whole document or on those parts that were relevant to them.

We reviewed the draft strategy and submitted our comments and feedback. We consider the strategy to be an important document for the future of the development of our industry, so we decided to take the time to review it thoroughly. We feel that our views as an industry stakeholder should be relevant and we trust that the authors of the document will take these into consideration.

Contents of the document

The priority areas of the strategy are well chosen, and we agree that all of them are important. For the current activities of Tepsivo, the areas of “data analytics, digital tools and digital transformation” and “innovation” are the most relevant and thus majority of our comments were within these areas. We will follow up with another blog post on these two topics in more detail.

COVID-19

The effect of the COVID-19 situation on the document is obvious. COVID-19 is mentioned several times throughout the document.

Probably someone at some meeting said that COVID-19 situation needs to be taken into consideration in the document and everyone agreed. No surprise there. It would be more surprising if that did not happen. However, the topic is not necessarily so relevant for this strategy overall (with the exception of “Availability and access to medicine” and maybe “Antimicrobial resistance and other emerging health threats”).

Trying to fix everything

The strategy document is tackling a large variety of issues, all important as mentioned already. The strategy has been split into six areas for a good reason, but it seems that there are still some issues with focusing to the topics. It seems that each of the six working groups wanted to take their crack at solving all the issues in the world in their explanation of the goals.

Is it a good strategy?

As we are not exactly experts on strategy, we took a look at what is the definition of strategy. According to Wikipedia it is something like “a general plan to achieve one or more long-term or overall goals under conditions of uncertainty.” And then we went to the next level, and checked out what is the difference between a good strategy and bad strategy.

Main problem of the document seems to be “fluff”. The document doesn’t suffer from a lack of high-minded concepts but then it lacks in specification or concrete steps. Second issue is with the goals and objectives. The document, in general, defines well what the goals and objectives are, but there are too many of them; five years can fly past quickly, especially for government officials. The strategy could use more focus and a specific action plan. There were also some minor issues with the objectives that we have pointed out in our feedback.

Conclusions

We agree with the selected strategic areas and believe these to be crucial to focus on. However, a comprehensive “strategy document” would benefit from defining concrete steps on how to achieve the laid-out objectives and how its success would be measured. This is overall missing in the current draft and we argue that for the final document, specific plan defining, for example, the type of technologies/AI/machine learning to be used and for what purpose.

Digital transformation is a dominant theme throughout the document (word “digital” mentioned 48 times) but very little specifics are mentioned. We believe that for a 5-year plan, EMA and HMA should have a solid plan for the type of technologies to be used and these should be a critical element in the strategy document.

We also believe that as part of the strategy, EMA should encourage collaboration with industry stakeholders such as specialized providers and consultancies whose daily work is to ensure compliance with EMA regulations. In our view, this is particularly relevant for the area of safety monitoring (our field) as a substantial proportion of overall Pharmacovigilance activities are currently outsourced to specialized providers who are the parties that in fact develop new solutions and best practices industry-wide.

Especially achieving the goals of digital transformation and innovation are in practice going to be led by these specialized companies. A closer cooperation between the regulator(s) and providers should be highly beneficial to meet the joint network’s strategic goals. Overall, we can see the document calls for collaboration with external stakeholders, but these seem to be limited to HTA bodies, NCAs, and industry associations. The strategy should emphasize the need for working with individual commercial companies, as well.

It would be interesting to hear if you sent your feedback, what kind of feedback did you give and what areas did you comment?

We will be following up with more specific comments and views on the two main strategic areas of our interest, digital transformation and innovation.