News

HDA UK MEDIA AND POLITICAL BULLETIN – 26 July 2017

MEDIA SUMMARY 

Growth in next-generation sequencing informatics market fueled by big data
European Pharmaceutical Review, Steve Bremer , 25 July 2017

The European next-generation big data genetic informatics system is predicted to be worth $500 million by 2021. The use of genomic data-sets to craft tailored prescriptions has become increasingly prevalent in Europe, leading to the more widespread use of end-to-end genetic mapping in prescribing and diagnosing illnesses. The current informatics systems are currently providing substantial benefits to life sciences and diagnostic firms, where competitive pricing has made genetic data much more easily available and harvestable. This comes after intensifying demand in the industry for genomic data. At the moment, further commercialization is prevented by country-level data protection laws, but most states are currently developing their own genetic data storage systems. In particular, Britain’s 100,000 genomes project is one of the leading programmes of its kind in Europe, and looks set to grow in the coming years.

Medicines and Healthcare Products Regulatory Agency (MHRA) Inspectorate Blog – Do wholesale distributors require pharmacovigilance agreements?
MHRA, Peter Twomey, July 26 2017

MHRA Good Distribution Practice (GDP) inspectors have received a number of queries from wholesaler distributors asking in what instances agreements are required between the marketing authorisation holder (MAH) and wholesale distributors for the purposes of fulfilling pharmacovigilance requirements. The Good Pharmacovigilance Practice (GPvP) Inspectorate has provided clarification on the MHRA Blog, and the full statement can be found in Full Coverage below.

PARLIAMENTARY COVERAGE

There is no parliamentary coverage.

FULL COVERAGE

Growth in next-generation sequencing informatics market fueled by big data
European Pharmaceutical Review, Steve Bremer , 25 July 2017

The European next-generation sequencing informatics market is predicted to be worth over $500m by 2021, supported by big data-driven clinical interpretation in novel areas, according to a new report.

Frost & Sullivan’s report predicts that strong demand from the biopharma Industry will encourage NGS informatics providers to deliver customised solutions. Reduced costs of sequencing costs have led to burgeoning genomic datasets, and these, coupled with data from multi-omics and electronic medical/health records (EMR/EHR), are fueling the adoption of big-data methodologies in data analysis, it says.

Growth Opportunities in the European Next-generation Sequencing Informatics Market‘ details unmet needs and highlights potential opportunities across the secondary analysis, tertiary analysis and storage solution segments.

“As the industry matures, users of NGS informatics services will seek seamless end-to-end genetic solutions in an easy-to-use format at competitive prices,” said Frost & Sullivan Analyst Neelotpal Goswami. “Intensifying demand from pharmaceuticals, biotech, and diagnostic firms will propel NGS informatics providers to develop customised solutions that address user needs – from sample analysis to actionable informatics.”

Trends supporting market development include:

  • Focus on personalised medicine across European nations such as France, Germany, and the UK, along with a number of pan-Europe initiatives
  • National-level genomics data collection and analysis initiatives, such as the UK’s 100,000 Genomes Project and the French Plan for Genomic Medicine 2025
  • Strong research and development and wider application of NGS informatics-based services in Benelux and the Nordics
  • Presence of cutting-edge NGS technology infrastructure in the region, like the Wellcome Trust Sanger Institute, a highly-educated population receptive to NGS technologies and significant government support.

“Europe is a fragmented market, where revenue potential varies significantly in individual countries,” said Mr Goswami. “Additionally, at a pan-European market level, countries have differing regulations and reimbursement practices that may hamper successful commercialisation of NGS informatics solutions. However, innovative approaches such as storing genomic data for analysis within specified geographic borders to match data storage regulations, and evolution in reimbursement policies that increase clarity and coverage for NGS-based tests, will support growth opportunities.”

Medicines and Healthcare Products Regulatory Agency (MHRA) Inspectorate Blog – Do wholesale distributors require pharmacovigilance agreements?
MHRA, Peter Twomey, July 26 2017

MHRA Good Distribution Practice (GDP) inspectors have received a number of queries from wholesaler distributors asking in what instances agreements are required between the marketing authorisation holder (MAH) and wholesale distributors for the purposes of fulfilling pharmacovigilance requirements. The Good Pharmacovigilance Practice (GPvP) Inspectorate has provided clarification below:

According to Article 1(17) of Directive 2001/83/EC, wholesale distribution of medicinal products is “all activities consisting of procuring, holding, supplying or exporting medicinal products apart from supplying medicinal products to the public…”. If a wholesale distributor could potentially receive safety-related information on behalf of the MAH, or if they are providing a service relating to pharmacovigilance, then they are effectively part of the MAH’s pharmacovigilance system. In this situation, contracts or agreements between the MAH and wholesale distributor need to exist, in order for the MAH to ensure that activities performed and services provided by these third parties are in accordance with applicable legislation and guidelines, and in order to ensure that all parties understand and formally agree to the tasks that have been contracted. In this blog post, the terms contract and agreement are used synonymously.

The good pharmacovigilance practices (GVP), are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union.
GVP Module VI.2.2 states that “Each marketing authorisation holder shall have in place a system for the collection and recording of all reports of suspected adverse reactions which are brought to its attention”. As indicated earlier, wholesale distributors may be a potential source of safety information. Hence, the MAH will need to have a mechanism to collect reports of adverse reactions received by wholesaler distributors.

GVP Module VI.B.7 outlines the reason why agreements between the MAH and wholesale distributors may be required “Where the marketing authorisation holder has set up contractual arrangements with a person or an organisation, explicit procedures and detailed agreements should exist between the marketing authorisation holder and the person/organisation to ensure that the marketing authorisation holder can comply with the reporting obligations. These procedures should in particular specify the processes for exchange of safety information, including timelines and regulatory reporting responsibilities and should avoid duplicate reporting to the competent authorities”.
As reports of suspected adverse reactions may be brought to the attention of wholesale distributors, agreements between the MAH and the wholesale distributor support the fulfilment of the collection and recording of these reports by the MAH.

Indeed, section 6.3 of the European Commission Guidelines on Good Distribution Practice of medicinal products for human use (2013/C 343/01) states “In the event of a complaint about the quality of a medicinal product and a potential product defect, the manufacturer and/or marketing authorisation holder should be informed without delay”. Complaints received by wholesale distributors may include reports of suspected adverse drug reactions and should be forwarded to the MAH, the implementation of an agreement between the parties may help facilitate this activity.

Factors influencing whether an agreement is required

The MAH needs to assess if the wholesale distributor they have engaged with are a potential source of safety information (such as reports of adverse reactions, medical enquiries or product quality complaints), and/or are providing pharmacovigilance services on behalf of the MAH, and whether an agreement is required to fulfil pharmacovigilance requirements. Some factors which are likely to result in an agreement being required include:

  • if the name and/or contact details of the wholesale distributor appears on product packaging, the patient information leaflet (PIL) or the MAH’s website,
  • if the MAH does not have a contactable presence in the market where the product is being distributed, which may increase the likelihood of the wholesale distributor becoming a point of contact by a member of the public or health care professionals (HCPs),
  • if the wholesale distributor is providing services which may increase their interaction with HCPs and the likelihood of receiving safety information, such as actively promoting products via a sales team,
  • if the wholesale distributor is performing pharmacovigilance services on behalf of the MAH, for example, undertaking follow-up of adverse events in their territory on behalf of the MAH, undertaking local literature searching activities or distributing risk minimisation materials.

The above list is not intended to be exhaustive and the MAH should consider all factors which may result in the wholesale distributor becoming part of the MAH’s pharmacovigilance system.
There may be situations when an agreement is not required, for example, if the wholesale distributor is not in a contractual relationship with the MAH and would not be regarded as a potential source of safet

safety information and thus would not form part of the MAH’s pharmacovigilance system.

Content of agreements

If an agreement between the MAH and the wholesale distributor is required, it should contain sufficient detail to ensure that pharmacovigilance requirements are met. It is the responsibility of the MAH to decide what provisions need to be included in these agreements, particularly considering the content required in agreements may vary depending on the parties involved. Some provisions which the MAH may wish to consider in agreements are outlined below, however, this list is not intended to be exhaustive and the MAH should use their judgement when deciding what information should be included in agreements:

  • the roles and responsibilities of each party
  • the types of safety information which should be collected and forwarded to the MAH by the wholesale distributor (e.g. suspected adverse reactions, lack of efficacy reports, product quality complaints etc.)
  • timeframes for the exchange of safety information between parties and case confirmation and/or reconciliation provisions
  • contact details of where the wholesale distributor should send safety information received to
  • how the transfer of outstanding safety information to the MAH will be handled should commercial arrangements be terminated
  • provision for the oversight of the wholesale distributor by the MAH (e.g. in process compliance measures and the right of the MAH to audit the wholesale distributor).

The MAH should consider how to ensure all parties are complying with the terms of the agreements, such as including wholesale distribution partners on the MAH’s risk-based audit programme, or implementing routine checks of pharmacovigilance relevant wholesale distributor activity, such as periodic reconciliation of reports of adverse events between the distributor and the MAH which may identify discrepancies in information exchanged.

Conclusion

In conclusion, when deciding if an agreement between the MAH and the wholesale distributor is required, the MAH needs to consider if the wholesale distributor is a potential source of safety information and/or performing pharmacovigilance tasks on behalf of the MAH, and implement agreements as appropriate. Provided the aforementioned factors have been considered, it is anticipated that there may be instances where an agreement between the MAH and the wholesale distributor is not required. The MAH should ensure that where an agreement is required, these agreements contain sufficient detail and provisions relative to the relationship between the MAH and the partner.

HDA UK MEDIA AND POLITICAL BULLETIN – 26 July 2017

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