Summary

1. The Pharmaceutical Industry Competitiveness Task Force (PICTF) was established in April 2000, and published its final report in March 2001. Included in the report (at Appendix I) is a detailed action plan setting out agreed actions following PICTF discussions. There were 69 actions in total.

2. This report describes how those actions have been taken forward in the year since the publication of the PICTF Report.

3. Of the 69 actions:

• 38 have been completed
• 24 have been incorporated into ongoing action or other joint work
• 7 are outstanding actions

4. This report follows the same chapter structure of the PICTF Report, summarising the work that has taken place, and identifying which actions have been completed, incorporated into other work, or remain outstanding, identifying actions by their number in the original action plan.

Developments in the UK Market

5. PICTF agreed that there should be close joint working between Government and industry on National Service Frameworks (NSFs), which set national standards for the NHS in clinical priority areas. There has been close collaboration between the ABPI and its member companies and teams in the Department of Health leading the development and implementation of specific NSFs. For instance:

• Discussions between ABPI and DH on the implementation of the Diabetes NSF Standards, published in December 2001. An ABPI representative has been appointed to the NSF Implementation Group
• A successful "Champions Conference" in March 2002 to support implementation of the NSF for Older People, organised jointly between DH and ABPI
• Dialogue has started on the new NSFs under development (for children, renal services and long term conditions).

6. The Government is committed to positive industry involvement in the NSF programme, which provides the opportunity for industry to make a strategic contribution to the development of better and more effective health care through the NHS. For its part, the ABPI has established committees on each NSF, bringing together interested companies to allow industry-wide involvement that goes beyond the specific interests of individual companies.

7. PICTF identified the potential for greater use by industry of NHS information, building on existing systems such as the General Practice Research Database, as the quality of NHS information and the databases that generates improves. This is work still in its early stages - as the PICTF report recognised, the issues to be addressed are substantial. DH and ABPI will continue to pursue this during the coming year.

8. It was agreed to work together on issues relating to information to patients on licensed medicines. During the year the Medicines Control Agency (MCA) and the ABPI have worked towards clearer definitions of information and advertising, and information that may be provided to patients by companies, and have developed guidelines to allow greater use of disease awareness programmes within restrictions on advertising. Industry has provided a model company website to the MCA. This work will also form an important part of discussions in the EU medicines licensing review ("2001 Review"), which includes proposals affecting the controls on information to patients.

9. The key PICTF actions on concordance (improving patients' use of medicines) have been completed. A joint Task Force on Medicines Partnership was set up, including an industry representative, and has met twice. A Project Team has been established at the Royal Pharmaceutical Society and a two year work programme agreed.

10. PICTF agreed a number of pieces of joint work on "non-reimbursed medicines" (medicines not available on the NHS or not recommended for NHS use). Legal advice was sought on whether a voluntary mechanism might be developed for placing products on Schedule 10 or 11, instead of going through the requirement of amending a Statutory Instrument. The answer was that it was not possible, so this has not been pursued. However, a number of possible ways to speed up the scheduling process have been discussed, and will be piloted when a suitable candidate product is identified for scheduling. Action to streamline the process for reclassifying prescription-only medicines, to make them available over the counter in pharmacies, was taken forward through a consultation document published in December 2001. The new streamlined process will halve the timescale of the existing process, allow for a short period of marketing advantage for innovative applications and introduce a dedicated target timetable for determination of applications made at any time during the year - allowing companies better to plan to reach the market at the right time for their product. The new process was announced in May 2002, and discussions with industry on implementation continue.

11. Finally, it was agreed that the Government and Industry would work together to maximise the likelihood of mutually beneficial advances from new developments in genetics. The industry is represented on the advisory panel for the forthcoming Green Paper on Genetics, and further dialogue is planned to help inform the Green Paper.

Intellectual Property Rights

12. During the PICTF process, an agreed Government/ Industry position was reached on international intellectual property rights in the context of access to medicines in developing countries. This position was widely disseminated and has formed the foundation of discussions during the last year. In the Summer of 2001 the Prime Minister asked Clare Short to chair a High-Level Working Group to allow Government, Industry and international organisations to consider together how to access to medicines in developing countries might be improved. A report to the Prime Minister is due in Summer 2002.

13. The action agreed on the UK approach to data exclusivity in the 2001 Review was completed. Discussions on an EU-wide outcome now continue as part of the wider 2001 Review negotiations. There was also intensive joint work on ensuring the IP and data exclusivity interests were adequately covered in the EU enlargement negotiations. This work has achieved a successful outcome so far, but there remains the important task of seeing it through to implementation.

14. The action agreed on pursuing price liberalisation of non-reimbursed medicines at EU level was successfully taken forward in the "G10" initiative. The final report of the G10 group, presented to Commission President Prodi in May 2002, included a recommendation that price controls across all EU member states should not apply to medicines not reimbursed by the state. This is now to be pursued through the G10 implementation process.

Regulation of Medicines Licensing

15. MCA and industry share a number of common objectives in the EU medicines Licensing Review (the "2001 review"). Within the context of PICTF, agreed positions that would form part of the basis of the UK position to be pursued in EU negotiations, were developed. At the time of the publication of the PICTF Report, the European Commission had not yet published its proposals. They were published in the Autumn of 2001, and negotiations got under way early in 2002. The actions agreed - for example to pursue optionality (ie allowing companies to choose either the centralised licensing procedure or the mutual recognition procedure) - are being taken forward in negotiations in the Council Working Group and in discussions with the European Parliament, alongside other issues that have been discussed with industry as key aims for the negotiations.

16. The IT environment in the UK (with the MCA's Information Management Strategy) and in the EU (with changes in EUDRA management) has changed significantly since the PICTF Report was adopted with a consequent impact on Action Point 40, the development of an IS/IT strategy within Europe. However, MCA, ABPI and its member companies have been working together on the electronic submission of dossiers using the eCTD format. ABPI and MCA have also been co-promoting the electronic submission of reports of adverse drug reactions (ADRs).

Science Base and Pharmaceuticals

17. The recommendations relating to this part of the PICTF Report were to take forward action on manufacturing, the skills base, industry/academia links, relations between Big Pharma and SMEs and on animals in scientific procedures.

18. Working together, Government and industry have completed most of the tasks to work to implement the recommendations. The BioIndustry Association completed a survey of the state of biomanufacturing in the UK. This was a working document rather than a formal report and was not therefore published. It provided the information for the BIA's "Faraday" application in 2001. Unfortunately, this application was not successful, as there were a large number of competing applications. The BIA are therefore submitting an improved proposal for the 2002/3 round.

19. There has been considerable work on the skills issues. Apart from the Roberts Review, Industry has identified research councils' key fields for further implementation of the MRes scheme and has been working on benefit-based proposals to put to the BBSRC and the EPSRC. Further discussions on specific proposals continue. The DTI sponsored a consultancy study on skills in the biotechnology sector, which also has implications for big pharmaceutical companies. The study is due to be published shortly.

20. Proposals for developing and obtaining funds for training programmes for industrial and academic liaison officers in universities and industry to strengthen industry/academia links are being considered . As the issues have much broader implications that just for pharmaceuticals and biotechnology they are being taken forward by CBI/AURIL, which have been liaising with DfES.

21. The DTI, working with the BIA, is constructing a 'BioPortal' to provide internet access to a broad range of biotechnology and biopharmaceutical information. This will assist in pharmaceutical companies' identification of suitable SME research partners and in seeking funding for databases. The portal is being funded through the Treasury's "Invest to Save" programme.

22. Reorganisation of the DTI will have a beneficial impact on many of the recommendations in the PICTF Report. In particular, the DTI will be working on improvements to industry support schemes to enhance their effectiveness. This should have beneficial effects on schemes to promote effective management of intellectual property arising from industry-sponsored collaborative research with academia.

23. Efforts are still being made to identify a suitable secondee to advise government on the pharmaceutical industry and inward investment. Within the re-structuring programme, DTI is actively promoting secondments between industry and government. It is intended to take up this PICTF recommendation as part of the DTI secondment programme.

24. Government has been particularly successful in taking action on streamlining licensing procedures and against animal rights extremists. The Home Office have set up a monitoring system to measure the time taken to process project and personal licence applications against the measure of 35 "clock time" days agreed in the PICTF Working Group. Three new inspectors have been appointed and there will be an increase in the total numbers from 21 to 33 over the next two years. The Home Office has also issued guidance notes to Certificate Holders on "best practice" for Ethical Review Processes and a checklist of common errors on project licence applications that would unduly delay processing an application.

25. The Criminal Justice and Police Act 2001 strengthened legislation against animal rights extremists, and the effects have been welcomed by industry and academia. Section 42 of the Act has been successful in reducing the number and severity of "home visits". Regulations to provide a secure register for directors' home addresses came into force on 2 April 2002.

26. As well as legislative action, the Home Secretary chairs a cabinet committee on animal rights extremism. The committee reviews the effectiveness of existing legislation and what further needs to be done, either more efficient application of that legislation or potentially through further legislation.

Clinical Research

27. PICTF identified a number of ways in which the existing strengths of the UK as a base for clinical trials could be improved, in particular through reducing delays in the system for approving and overseeing clinical trials. The actions agreed in this area have been taken forward jointly during the year and overseen by the PICTF clinical research working group, which has continued to meet under the chairmanship of Sir John Pattison and Vincent Lawton.

28. An updated report from the group was published in March 2002 (available at www.doh.gov.uk/pictf). This sets out the action taken as a result of the main PICTF report, including:

• New procedures for ethics committees and NHS trusts to consider applications for clinical trials including tighter timescales and considering applications in parallel.

• Measures on quality of industry applications for first time approval to avoid further information being sought unnecessarily, and the implementation of the Research Governance Framework for Health and Social Care in the NHS.

• Revised guidance to the NHS on cost-recovery for industry trials hosted by the NHS, to improve transparency.

29. Performance will be monitored through indicators that have been developed for inclusion in the annual PICTF competitiveness and performance indicators. In addition, the Research Partnership Agreement proposed in the main PICTF report was concluded. It was announced by Lord Hunt and Tom McKillop in March 2002. The updated report sets out this agreement as an annex.

30. Discussions have also taken place between MCA and Industry on the UK's implementation of the EU Clinical Trials Directive. Further work will continue leading up to and following publication of the European guidelines on implementation of the Directive.

Competitiveness and Performance Indicators

31. The PICTF Competitiveness and Performance Indicators, to be published annually, provide the objective data to underpin assessments of how well the UK is performing in the key areas identified by PICTF as crucial to its competitiveness as a location for pharmaceutical companies.

32. Following the publication of the PICTF report, a great deal of technical work needed to be done to further define the statistical basis for the indicators, to gather the data, and to compile the indicators in an accessible form for publication. This work was carried out jointly by economists from the Department of Health and the ABPI's Office of Health Economics. The first set of indicators was published in December 2001.

33. The most important purpose of the indicators will be for assessing trends over time, so the first set serves mainly as a baseline for future comparison. However, some conclusions could be drawn from the first set, namely that the UK currently has:

• a pharmaceutical industry that contributes significantly to the UK economy;
• a comparatively strong scientific research base;
• an impressive record of pharmaceutical innovation;
• a relatively rapid regulatory process for medicines compared to other countries;
• relatively slow uptake of medicines by prescribers.

34. These and other trends will be followed as further annual indicator sets are published.

Conclusion

35. The Government and the research-based industry demonstrated their commitment to work together for mutual benefit during the PICTF process. That commitment has continued through partnership work in the year since the PICTF Report was published.

36. The Ministerial Industry Strategy Group (MISG) - which held its first meeting in November 2001 and its second in May 2002 - continues to oversee the follow-up to PICTF. This includes ensuring that the PICTF actions are followed through, but also (and increasingly, as the specific actions are completed) taking forward the aims underlying PICTF, and taking a strategic view of the competitiveness of the UK into the future.

MISG Secretariat
May 2002

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