CSR

Delivering responsibly

To our employees

Phytopharm places considerable value on its employees and seeks to keep them informed on the Group’s business strategy and objectives to assist them in working towards these goals. This is achieved through formal and informal meetings where employees have the opportunity to ask questions as well as receive information.

Employee training and development requirements are assessed as part of the performance appraisal process. Additional training is undertaken as required to provide staff with continuous professional development.

The Group operates an equal opportunities policy. Full consideration is given to all job applicants, irrespective of gender, age, marital status, disability, sexuality, race, colour, religion, political belief, ethnic or national origin or any other conditions not relevant to the performance of the job, who can demonstrate that they have the necessary skills and abilities.

Phytopharm is committed to health and safety and has well-developed health and safety policies and procedures to safeguard all of its employees, partners, contractors and visitors. The Board is aware of its legal and moral obligations for health and safety at work and is committed to preventing accidents and minimising occupational ill health.

To ethical business practices

As a semi-virtual Company, Phytopharm has adopted the key principles of SA8000, Social Accountability International’s standard that provides a comprehensive and flexible system for managing ethical workplace conditions throughout global supply chains. In adopting these principles Phytopharm addresses the issue of fair treatment to all its employees who are required to follow Code of Conduct that include social awareness. Phytopharm also promotes SA8000 standards amongst its partners, suppliers and contractors worldwide. Assessment of compliance to these principles and other applicable regulatory or legal requirements is through audit and subject to continuous improvement. Action plans are agreed and implemented to raise the level of compliance where appropriate.

By starting with a plant extract that has a history of clinical use Phytopharm’s unique approach helps reduce the need for lengthy preclinical animal testing. Nevertheless, regulatory authorities worldwide require that all new medicines must be subjected to rigorous safety testing in animals and in human clinical studies before they are approved for use to protect people from potentially toxic effects. The use of tests on animals to develop medicines is the subject of enormous ethical sensitivity that rightly commands a high level of public interest. Phytopharm is committed to implementing the three R’s – Reducing the number of animals used for research, Replacement by non-animal methods whenever possible and Refinement of the techniques used to eliminate or reduce suffering and improve animal welfare. Phytopharm has no animal testing facilities itself but uses regulated and licensed Contract Research Organisations and other licensed institutions that comply with government requirements. Phytopharm implements robust review processes to ensure the highest quality animal welfare standards are maintained.

To the environment

Phytopharm recognises that protecting the environment is a primary corporate responsibility and that environmental matters are not just the responsibility of the Board of Directors, but also an area in which each employee, corporate partner and third-party contractor has a contribution to make. Phytopharm therefore encourages all employees, partners and contractors to operate in an environmentally responsible manner. Where appropriate these requirements have been incorporated into the Company’s standard operating procedures and the environmental performance of contractors is reviewed as part of the audit process. It is Phytopharm’s policy to undertake reasonable measures to assess the environmental impact of its operations, processes and products and the Company aims to continuously improve environmental performance and compliance within these areas.

Biodiversity Treaty

Phytopharm’s policy is to embrace the principles of the International Convention on Biodiversity and address the challenging issues it presents. The Group endeavours to enter into commercial arrangements with organisations and companies in third world countries that bring financial and technology transfer rewards to the originating country or inventor. These financial rewards may take the form of milestone payments or royalty shares in successful products. Examples of technology transfer include training of farmers to cultivate botanical raw materials in accordance with the principles of Good Agricultural Practice (GAP) and the installation of Good Manufacturing Practice (GMP) compliant facilities and training of staff responsible for its correct operation and maintenance.

Quality Assurance

As a responsible company, Phytopharm’s products are developed in accordance with recognised quality guidelines and appropriate national and international legislation to ensure the efficacy of the product and the safety of the consumer. In order to achieve this, the Company has adopted the following guidelines:

Good Agricultural Practice (GAP)

The principles of GAP are applied to the cultivation and post-harvest processing of botanical raw materials. The Group’s GAP manual and associated technical documentation have been developed with reference to recognised codes of practice. The manual provides a framework for cultivation protocols that are implemented by working with local farmers, agronomists and horticulturalists in the countries where crops are grown. The cultivation protocols are developed to combine local practice with the principles of GAP to ensure a synergy between developing agricultural systems and western agricultural practices. Compliance to the protocols is assessed by the review of crop record sheets and monitoring visits to the growing sites.

Good Laboratory Practice (GLP)

The Group requires that contractors involved in the conduct of key non-clinical studies and the analysis of such studies apply the appropriate level of GLP to their facilities and the conduct of studies therein. These requirements are detailed in the GLP regulations Statutory Instrument 199 No. 3106 and they have been incorporated into the Company’s quality system. Compliance is reviewed by routine monitoring visits and/or audit and training may be provided to ensure the level of compliance is acceptable.

Good Manufacturing Practice (GMP)

The Group requires that all contractors directly managed by Phytopharm and involved in the operational aspects of manufacture, analysis, packing, labelling, release, storage and distribution of its materials and products apply the appropriate level of GMP to their facilities, as defined in GMP regulation and guideline documents.

These practises are mandatory requirements for products designated for use in clinical trials conducted in accordance with competent authorities’ regulatory requirements. Guidelines are detailed in UK, European, US and ICH publications and have been incorporated into the Company’s quality system. Compliance is reviewed by routine monitoring visits and/or audit and training may be provided to ensure the level of compliance is acceptable.

Good Clinical Practice (GCP)

GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting studies that involve the participation of human subjects. Studies conducted in Europe and North America must have ethical and regulatory approval prior to initiation and compliance with the stated protocol is independently monitored and further assessed by audit. These actions help to provide assurance that the rights, safety and well-being of study subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. These requirements have been incorporated into the Group’s standard operating procedures and working documentation.