What an association does for the profession
Professional associations represent the profession collectively, develop standards and work to improve members’ working conditions. Their choices about representation, ethical commitments and funding affect the profession beyond the services an individual member receives.
Visibility and representation
Medical-writing associations aim to defend and promote the profession by pooling resources and effort so its work is recognised, respected and valued. A low professional profile may leave colleagues with unrealistic expectations, such as expecting a full protocol in a couple of days. Lack of visibility can lead to underappreciation and poor remuneration; combined with lack of respect, this can lower morale, while low status may discourage future entrants. Without a prominent association, practitioners can find it harder to promote their profession, maintain standards through professional education, find work and gain recognition for their skills. Highly visible professions benefit from public understanding of their skills and value, and from associations that monitor standards and seek to protect members and the public.
When IR35 was introduced in the UK in 1999, freelancers formed the Professional Contractors Group to connect their community with policy makers and help prevent harmful future policies. Several thousand joined in its first few months; by 2014 PCG had around 21,000 members from different freelance disciplines and an active voice in government and industry. PCG co-founded the European Forum of Independent Professionals, which worked with the European Parliament for recognition of independent working as a legitimate alternative to employment and for specific consideration of independents in policy making. Joining such associations can help define the sector, demonstrate its economic value and support more sophisticated regulation and government assistance.
Professional and ethical standards
Associations develop and publish professional and ethical standards and fair business practices covering confidentiality, independence, objectivity, misconduct, legal issues, clients and conflicts of interest. Members are encouraged to follow these standards to maintain the profession’s reputation, and associations promote standardisation through technical guidelines and targeted workshops. Maintaining standards can help safeguard pay and working conditions.
EMWA’s standard-setting activities around its 2016 programme included publication-writing guidelines, a joint EMWA–AMWA Budapest Working Group reviewing standards, and a pharmacovigilance special interest group.
An in-house medical editor and translator at a German university hospital found that referring to EMWA workshop standards, particularly for style, gave corrections more professional standing than relying on personal intuition.
AMWA planned to add its Code of Ethics to membership application and renewal forms from 1 January 2009, asking applicants and renewing members to confirm they had read it and agreed to conduct their professional interactions accordingly. Its board amended the bylaws in October 2008 to make acceptance of the Code part of active-membership approval requirements. This followed ethics-awareness work through journal articles, letters to other publications’ editors and conference sessions; in 2008 the executive committee recommended at least one ethics open session at each future annual conference and ethics discussions within workshops. Placing the Code on the forms was intended to increase familiarity and encourage its application. AMWA explicitly said it would not monitor or enforce adherence and did not want members to appoint themselves ethics police.
An association can also contribute to an external standard: a UK expert group established in late 2021 to develop a horizontal clinical-evaluation standard included a regulatory authority, a notified body, EMWA, a trade association, manufacturers and consultancies. In 2022, the draft was intended to become an ISO standard for clinical evaluation of medical devices through an ISO working group; no availability date was then known.
Defence of the medical-writer role
During 1991–1992, a proposed FDA policy threatened to restrict freelance and staff medical writers’ roles in pharmaceutical research, scientific publications and continuing medical education. AMWA’s Task Force on Scientific Writing drafted guidelines explaining writers’ work, their specific skills and training as team members, and how the proposed policy threatened members’ livelihoods. The task force met the FDA, which adopted many of its recommendations; AMWA’s 2011 account credited the work with helping establish medical writers’ role in the pharmaceutical industry. The discussions also led the task force to revise AMWA’s Code of Ethics in 1994 with specific standards for accuracy, balance and scientific rigour in all scientific materials.
The AMWA–EMWA–ISMPP Joint Position Statement on the Role of Professional Medical Writers in preparing manuscripts for publication had German, Italian, French, Japanese and Chinese translations by early 2018. Romanian, Hungarian and Portuguese versions were planned to extend its reach among non-native English speakers.
In April 2022, EMWA and the Australasian Medical Writers Association began strengthening their partnership, intending to create opportunities for education and future global position statements.
Employers and workforce needs
After its inaugural Medical Writing Executives Forum, AMWA planned an advisory council to use employers’ feedback to identify training priorities and develop goals, helping prepare existing and future medical communicators for biopharmaceutical workplace demands. Executives at its 2019 forum identified training, mentoring and value as the three concerns requiring immediate attention, and 23 participants volunteered to help. In 2020, the Regulatory Writing Advisory Committee was to assess gaps in AMWA’s regulatory-writing education and recommend topics and experts; an ad hoc workforce committee had already proposed training topics and a curriculum roadmap in 2019, with publication planned for 2020. A mentoring workshop was in development for the October 2020 conference and company training, while the Medical Writing Executives Council was to work on quantifying medical writing’s value over the following year.
Funding and membership boundaries
In 2013, the Australasian Medical Writers Association gave writers working solely in public relations or product and service promotion affiliate membership, with access to services but no vote. The distinction had been controversial from the association’s early years, when promotional writers disputed the claim that they were not journalists. Technical and regulatory writers from pharmaceutical and medical-device companies could be members, but the association accepted no direct or indirect sponsorship from those industries.
That sponsorship restriction left the association with a relatively small budget and no paid positions, with conference speakers reimbursed in cab fares and coffees. Its events emphasised evidence-based medicine, ethical issues such as ghostwriting, writing skills and assessing hype in news. The 2012 Social Justice in Health conference included Aboriginal and Torres Strait Islander and refugee health alongside writing, editing and social-media sessions.