The Life Stages of Health Data

To enable effective sharing, data must be properly curated over its life-cycle and released with the appropriate high-quality metadata. This is the responsibility of the data owners who are usually those individuals or institutes that have received
funding to create or collect the primary data. ...From 1 January 2006, all applicants submitting funding proposals to Medical Research Centre, MRC, must include a statement explaining their strategy for data preservation and sharing. ... Applicants who consider data arising from their MRC-funded proposals not amenable to
sharing must provide explicit reasons for not making the data available.1


The life stages of data

Data sets go through several stages, and this has implications as regards access. Data begin as raw data, data as initially measured and recorded. These are transformed into cleaned data by being qualitycontrolled and having redundancies removed, evident errors of transcription or coding corrected, and so on, and their filing and indexing improved. As they are studied they become augmented data by
incorporating derivative or ‘built’ data, i.e. inferences drawn from multiple initial data (such as the date of onset of illness, established by reviewing clinical
measurements along with interview data), or by receiving new data from studies based on the resource, or by having data from the analysis of materials added to them. As mature data, which means different things for different data, data sets are held in databases, stored, or archived. Anonymised versions may be prepared.


Collections evolve in other ways over time. Paper files may be translated into electronic format, and earlier electronic data systems may be upgraded to more
modern ones. Newer coding systems may be adopted. Phenotypic health or social data collections may have genotypic data spliced onto or linked with them. Data may be linked with materials. Once dynamic collections may reach the fullness of age,
or lose support and become legacy collections, for which decisions have to be made about caretaking or destruction. At any time custodianship or financial sponsorship may change.

- Whether in any instance secondary access is appropriate depends on, among other things, how mature the data set is, how thoroughly it is documented, and how searchable it is. Raw data are rarely of use to people outside the unit collecting
them. Although the original collectors may know how the subjects were selected and why, what questionnaires were used, what measurement techniques were employed, how samples were treated, what codes were used, and so on, they may not have taken the (considerable) trouble to write all this up in a way that would allow a competent but
‘cold’ accessor to analyse the data properly. Moreover, because the current custodians may not have been involved in earlier stages, even they may be unaware of
all the soft areas and pitfalls. Data sets cannot be used effectively by secondary researchers – or by primary researchers either, for that matter – unless the
collection and its variables are thoroughly documented. Access decisions must take all of this into account.


Upon any transferring of data to third-party archives or depositing of samples in storage centres beyond the direct custodianship reach of the resource builders,
a variety of safeguarding, documentation, and access issues must be attended to.


1.‘MRC Statement on Data Sharing and Preservation Policy’. Medical Research Council; September 2005. www.mrc.ac.uk/index/
strategy-strategy/strategy-science_strategy/strategy-strategy_implementation/strategy-other_initiatives/strategy-data_sharing/
strategy-data_sharing_policy.htm [accessed 21 December 2005].

Source: Wellcome Trust; www.wellcome.ac.uk
ACCESS TO COLLECTIONS OF DATA AND MATERIALS FOR HEALTH RESEARCH;
A report to the Medical Research Council and the Wellcome Trust, By William W Lowrance





Health Research

Oxfam believes that the potential for pharmaceutical companies to contribute more substantially and effectively towards increasing access to medicines for poor people in developing countries is not being met, and that there are three factors that have prevented companies from moving forward.

First, companies’ pursuit of strategies that address access to medicines merely as a reputational problem has resulted in patchy, ad-hoc approaches which have failed to deliver sustainable solutions.

Second, the industry’s responses to flagging financial performance – hiking up prices, aggressively defending patents and prolonging existing ones through ‘ever greening’ rather than investing in research and development of new medicines – have undermined needs for lower prices, flexible approaches to patenting, and R&D investment into diseases relevant to the developing world.

Third, the industry’s failure to comprehend access to medicines as a fundamental human right enshrined in international law, and to recognise that pharmaceutical companies have responsibilities in this context, has prevented the adoption of appropriate strategies.

It is clear that there are pressures on the pharmaceutical industry to change course. Increased financial burdens on health systems due to ageing populations and changing disease burdens are stimulating calls for lower prices from both North and South. The industry is now challenged to be more transparent about its price rationale so that governments and public-health advocates can request greater alignment between the prices set and purchasing power. The intellectual property regime and the market-driven model of drug development are criticised for not delivering real innovation required to relieve the global public-health crisis.
At the same time, investors are clearly concerned that this industry is not delivering the profits that it used to. Emerging market economies are being identified as the possible panacea to this flagging growth. There are enormous opportunities in these markets, including lower costs to conduct R&D and clinical trials, and low-cost manufacturing. These economies also offer substantial market potential. However, for this to be realised, the industry will have to recognise that serving these markets requires a vastly different approach: one which reflects the significance of massive income disparities, the impacts of high prices on increasing vulnerability and insecurity, and the need for medicines that are relevant and adaptable to poor settings.

Pressures on the industry to meet society’s expectations of access to medicines will continue for a number of reasons:

First, a growing number of developing-country governments are making serious commitments towards achieving viable health services and equity of access. Without a solution to the problem of access to medicines, they cannot meet their goals and obligations to their populations. In the developing world, where the majority of people live in poverty and are highly sensitive to price rises, companies will have to respond by implementing sophisticated differential pricing policies correlated to different income levels or by instituting flexible patent policies to ensure the desirable low price is achieved.

Second, the epidemiology of public health is changing, with a more diverse range of diseases that require appropriate products. For developing countries particularly, their specific contextual realities need to be taken seriously: new products are needed, formulations need to be usable, and drug information and labelling should be comprehensible. R&D will have to be tailored to end-use realities.

Third, demands from civil society for the industry to deliver their end of the social contract are likely to grow and become more exacting. As the current models and incentives for delivering medicines that are suitable, usable, and affordable for poor people come under increasing scrutiny, this will add to the growing pressure upon the pharmaceutical industry to adopt different strategies that better meet global health needs.

If companies continue a slow evolution of the existing approach without addressing society’s expectations, they are likely to fall seriously short of meeting the challenges of access to medicines.

Now is the time for companies to take a bold look at new ways of doing business, incorporating a social equity bottom line into their thinking, working more flexibly, transparently, and practically with a wide range of stakeholders. The current inertia on access to medicines can be overcome by placing concerns about affordability and availability at the core of business decision-making processes and operations. To do so will require strong leadership and long-term vision.

Investing for life, Oxfam Briefing Paper, November 2007