Red Biotechnology: Legal Compatibility is Color-blind

/ / Legal x-rays

“No other sector holds the promise to enhance quality of life, productivity and environmental sustainability through innovation like biotechnology, while also benefiting Europe’s economy and research base”. Carlo Incerti, Chairman of EurapaBio, 3η EuropaBio event on the Benefits of Biotechnology, Brussels, 23 June 2015

As time goes by, the term Biotechnology becomes rifer with meaning – and color: Medical or red Biotechnology, Agricultural or green Biotechnology, Industrial or white Biotechnology and finally, Marine or blue Biotechnology provide lots of overlapping solutions that soon may seem color-blind.

Nowadays, 350 million patients benefit from the direct use of biotech medicine in order to treat and prevent chronic illnesses, such as heart attacks, leukemia, diabetes, hepatitis & rare diseases.

Beginning with Orphan Drugs: as of November 16th 2015 and until February 16th 2016, the European Commission holds its Public Consultation Review Process of the Orphan Regulation (141/2000 EC), in order to issue a “Notice” on the application of Articles 3, 5 and 7 of the Regulation. In particular, the meaning of a significant benefit is being reviewed in order to clarify what actually constitutes a significant benefit of an orphan drug vis-a-vis another product already authorized. The aim of the legislation is threefold: 1. to encourage the development of orphan drugs for communicable diseases (e.g. Ebola), 2. to introduce the orphan criteria for a new subset of the condition when a sponsor extends the use of its product after marketing authorization and 3. to clarify the criteria on the transfer of orphan designations between sponsors respecting fair competition.

All interested parties may contribute by emailing:

Advance Therapy Medicinal products (ATMPs) i.e. gene therapy for cancer, adult cell stem therapy or tissue-engineered medicinal products fall under EC Regulation 1394/2007 on Advance Therapy Medicinal Products. Therefore, a few months ago, the first ATMP containing stem cells for the treatment of moderate severe limbal cell deficiency (due to physical or chemical burns to the eyes) in adults was EMA[1]-approved.

Another issue resolved: biosimilars lacked a specific definition in EC Directive 83/2001 on medicinal products for human use. The ΕΜΑ issued an EU Guideline in April 2015 characterizing a Biosimilar product as “highly similar to the reference medicinal product in physicochemical and biological terms”. Let us remind ourselves that Biosimilars can only be authorized for use, once the period of data exclusivity on the original “reference” biological medicine has expired. Which means, at least 10 years (8+2+1).

In contrast with the United States’ FDA which evaluates biosimilar interchangeability with the original products, ΕΜΑ is of the opinion that “interchangeability rests with the EU Member States”. The Member States deny in their vast majority biosimilar interchangeability; however, if a physician has not prohibited the substitution, a pharmacist in France can substitute a biosimilar with a prescribed biological product. And moreover, the new rules cannot be implemented until the relevant decrees regarding the precise set of conditions required for biosimilar interchangeability have been adopted.

Furthermore, Transparency & Big Data are top legal issues that Biotech companies should address. In particular, following the issuance of the Regulation 536/2014 on Clinical Trials and the pharma companies’ liability to publish their full clinical trials data as part of the approval procedure, novel indications are often revealed rendering difficult to patent them at a later date.

Finally, the Informed Consent of patients has been further enforced and even more tightly. Examples of best practice enforcement can be found in places such as the Personal Genome Project. This requires a perfect score on a test before even the participants can enter their name, in order to ensure that the patient fully understands the meaning of her consent.

Our law firm’s comment:

Τhe different legal regimes between Europe and the US and robust intellectual property protection are first-class issues in need of resolution by the Biotech companies themselves.

Moreover, Biosimilars interchangeability will certainly, in our opinion, constitute, the biggest litigation challenge in the near future with core issues in Safety, Efficacy and Quality.

[1] European Medicines Agency