As a global pharmaceutical company with national marketing companies or major branch offices in 59 countries, we face an increasing level of complexity in the various regulatory and legislative environments in which we operate. In addition, our sales and marketing effort uses a wide variety of communication channels, ranging from traditional face-to-face contact through professional sales representatives, to the Internet, which plays an important role in informing doctors, pharmacists and others about AstraZeneca’s medicines. In order to ensure that our employees manage these complexities consistently and behave appropriately, we have a range of policies, supported by full and detailed training and monitoring and auditing of these activities.
We are committed to ethical sales and marketing practices worldwide that, as a minimum, meet or exceed the standards set by external regulations and codes of practice. To that end, we require all our national companies to have codes of practice in place that are in line with our own global Code of Sales and Marketing Practice and are at least as restrictive as all relevant external codes.
Over the past 24 months, AstraZeneca and all our affiliate companies outside North America have introduced a new, strengthened code of sales and marketing practice, supported by extensive training of all staff in all countries. Each local code provides details about what is permissible and what is not and the financial limits, in local currency, for the hospitality associated with meetings and scientific congresses. In the US, we have continued to refine our extensive set of sales and marketing policies to provide greater clarity to staff on our expectations for ethical business conduct in the evolving external environment. We have also continued to reinforce new and existing policy through communications and training of all employees.
Line managers throughout our marketing companies monitor compliance within their teams, supported by dedicated compliance professionals, who also work to ensure that appropriate training in sales and marketing practice is provided to all relevant staff. Each Marketing Company President chairs a local Compliance Committee and most local management team members are included. In the US, the Executive Director, North America, has delegated compliance oversight to the Business Integrity and Assurance Team (BIAT), which is headed by the VP Business Operations and includes senior representatives from across the business.
We also have a nominated signatory network that focuses specifically on approving promotional materials for release, to ensure that these meet all applicable internal and external code requirements. At a global level, our Group Internal Audit teams conduct local compliance audits within our Marketing Companies and Regional Offices. Marketing Companies outside North America conduct their own local audits under the control of the Local Compliance Officer, reporting to the Regional Compliance Officer.
Information concerning instances where our practices are not up to the standards required is collected through our continuous compliance reporting process and reviewed by senior management. As appropriate, serious breaches of the code are reviewed by the AstraZeneca Board and the AstraZeneca Audit Committee, led by Non-Executive Director, John Buchanan.
Significant breaches are discussed at the local Compliance Committee in the relevant country, and may also be included in the agenda of our Global Compliance Committee to ensure that lessons learned are captured and shared across our organisation to drive continuous improvement in performance worldwide.
Sales and marketing - confirmed breaches of external codes
 The different national external frameworks for regulation of sales and marketing practices create a challenge in interpreting the key performance indicator that we introduced in 2005 (the number of cases of confirmed breaches of codes or regulations ruled by external bodies). Nevertheless, the KPI provides a benchmark against which to measure our performance over time. In 2007, we identified a total of 32 such cases (44 in 2006), based on information gathered from 59 countries in which we have AstraZeneca marketing companies or branch offices where we have significant subsidiary operations.
We believe this decrease reflects our continuing commitment in this area, and arises primarily from our strengthened internal procedures where our strict code of practice requires that medically qualified individuals authenticate all promotional or scientific material in advance. The decrease should also be seen in the context of the continuing rise in strict standards from national and international codes.
Our 2007 figure includes cases where our promotional materials were challenged by competitor companies. In addition there were some cases where, while not confirmed breaches, regulatory authorities raised concerns with us.
We take all breaches very seriously and take appropriate action to prevent repeat occurrences. This may include re-training, discipline, or other corrective action up to and including dismissal, depending on the circumstances. For example, our marketing company in the UK were publicly reprimanded by the industry's regulatory body (the PMCPA) on two counts during 2007; one for assisting a primary care trust with a guideline document and the other for supporting an independent article in a professional journal. In both cases there was a failure to treat the materials as promotional items. Both incidents were followed up with detailed action plans, including comprehensive training programmes, revision of existing processes and standard operating procedures (SOPs), the introduction of new processes and SOPs, and disciplinary sanctions.
We can also gain useful information by examining the number of breaches relative to other companies’ performance where such data are made public by the authorities. AstraZeneca accounted for approximately 1% of all international breaches (3% in 2006), and while our number of breaches has fallen, the total for the industry as a whole has increased.
Accusations of inappropriate sales and marketing activities sometimes reach the press and this is a part of the appropriate scrutiny that the pharmaceutical industry undergoes. When these incidents are examined by external code of practice or regulatory bodies, they may or may not conclude that the criticism was well founded and constituted a breach. Only confirmed breaches are included in our KPI. Internally, all such incidents are fully investigated and appropriate action taken, irrespective of whether a breach has been confirmed. The content of this page was externally assured by Bureau Veritas, February 2008 |