Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020

Lord Lansley Excerpts

Friday 27th November 2020 Lords Chamber

[Lord Lansley (Con) [V]]

My Lords, supplementary protection certificates have been a feature of EU patent protection for medicines and plant products for some 30 years. I am very grateful to my noble friend Lord Callanan for setting out the structure of these regulations and their purposes very clearly. Of course, as we exit the transition period, in the absence of a mutual recognition of marketing authorisations between the United Kingdom and the EU regulatory authorities, it is necessary to provide for the SPC systems to work both in Great Britain and Northern Ireland. These regulations deliver such a system.

The timing of our scrutiny of these regulations is interesting. On Wednesday this week, just two days ago, the European Commission published its pharmaceutical strategy for Europe alongside its intellectual property action plan and its evaluation document on the system of supplementary protection certificates. That evaluation offered some interesting observations on the impact of SPCs in meeting their objectives. Of course, the principal purpose was to promote the quantum of innovation in Europe. The level of global R&D in new medicines remains high. The US is the largest component of that, and the proportion of new chemical entities originating in the United States has grown, with Europe in second place but China catching up fast.

The evaluation found that SPCs are valued by stakeholders, and it further suggested that they have contributed significantly to the return on pharmaceutical R&D in Europe. It calculated—I do not vouch for this—that 13% additional turnover has resulted from access to SPCs where they apply. Of course, this is only for new active pharmaceutical ingredients—APIs—and not for patents for such things as new formulations. None the less, this was able to support higher levels of R&D: an estimated €37 billion in total, which is sufficient for the development of between 39 and 62 new treatments.

The regulations for the European Union also have the objectives of supporting the location of pharmaceutical research within it and securing a harmonised framework for SPCs in Europe. The evaluation did not offer definitive evidence on the former—the location of R&D investment in Europe—and it reported little progress on the latter. As one might expect, the European Commission strategies published the day before yesterday now focus on what they describe as the “fragmentation” of the SPC system. With the establishment of the Unified Patent Court—alongside the European Medicines Agency, of course—according to my interpretation of the documents, the European Commission is now looking for the SPC to be a European, rather than a nationally determined, right.

So does any of that make any difference to us? Yes, in that the incentive to seek a marketing authorisation and an SPC in the European Union will be further strengthened and the regulatory costs in the EU will be less if one system is created. We are not in the Unified Patent Court. I recall the views of the noble Earl, Lord Devon, on that subject recently so I will not repeat those.

The United Kingdom is 3% of the global pharmaceutical market but we are 10% of global pharmaceutical research and development and of new innovations. There are many reasons why that is the case, and I believe that we can sustain that; indeed, it is one of the principal subjects for debate as we are considering the Medicines and Medical Devices Bill. SPCs themselves are a modest contributing factor but we should make the protection for new APIs in the UK at least comparable to that in the European Union. The simplest way to do that would be through the mutual recognition of marketing authorisations and, even better, shared work on the scientific evaluations leading to that. However, if we cannot achieve that, we could pursue an aligned structure for SPCs.

I offer a few questions to the Minister, partly because of my own lack of understanding, and I would be grateful for his response. First, I understand that a Swiss SPC is recognised within the European Economic Area by virtue of the fact that it is applicable in Liechtenstein. Logically, would a UK SPC be similarly recognised within the EU single market by virtue of its direct applicability in Northern Ireland?

Secondly, if an SPC is granted by the European Medicines Agency that applies in Northern Ireland but no marketing authorisation is given to that product in Great Britain then, at the point when the SPC takes effect, the opportunity to extend the territorial application of that SPC will end. That should be a rare event as there may well be a period of some years between the SPC being granted and it coming into effect. However, is it necessary for that option to be removed? The principle of one SPC per product applies, but can the Intellectual Property Office in this country enable a European supplementary protection certificate to be recognised, applying for the same period as it would have remaining effect elsewhere in the European Union?

Thirdly, the so-called Bolar exemption is important for generic biosimilar producers so that they can meet the trial data requirements to offer competing products at the end of exclusivity. The Commission’s IP action plan talks of further clarifying the provisions relating to this, so we may see legislation in the EU. Will the United Kingdom seek to do the same and keep our law in this respect in line?

Lastly, could my noble friend explain further the legal provisions on the granting of the six-month paediatric extension to which he referred? Is this achieved in the human medicines regulations amendments that we are to consider next Wednesday, which were also laid in mid-October? Why was Article 36 of the EU human medicines regulation excluded from applying in Northern Ireland by the protocol? Does that not create a potential discontinuity between the SPC for a product and its paediatric extension? I would be grateful to understand this better, not least before next Wednesday. I am grateful for the opportunity to ask a few questions on this.